RSV - Respiratory Syncytial Virus

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Respiratory Syncytial Virus (RSV) Vaccine

Respiratory syncytial virus (RSV) is the primary cause of serious respiratory disease in infants and young children worldwide. The virus is also increasingly recognized as a significant pathogen in elderly populations. Bronchiolitis or pneumonia results in 25-40 percent of RSV infections of infants and between 0.5 and 2 percent of these infections result in hospitalization. Despite the incidence and severity of these infections, there is no RSV vaccine available. Immunoprophylaxis against RSV of high-risk infants remains the only effective defense against this viral disease and there are no approved preventatives for the elderly.

In October 2011, Novavax announced positive top-line results from a Phase I clinical study of its RSV fusion (F) recombinant nanoparticle vaccine candidate. Novavax reported that the RSV vaccine candidate was well-tolerated and highly immunogenic, inducing levels of functional immunity that could potentially correlate with protective immunity in future trials.

www.novavax.com/go.cfm?do=Page.View&pid=13

Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine

This study has been completed.

First Received on February 2, 2011. Last Updated on March 6, 2012

Sponsor:

Novavax

Information provided by (Responsible Party):

Novavax



ClinicalTrials.gov Identifier:

NCT01290419


Purpose


A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age).

Study Objectives:

Primary:
•To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations.

Secondary:
•To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations
•To confirm the "dose sparing" and "value added" effects of the aluminum phosphate adjuvant


Condition:
Respiratory Syncytial Virus Infections

Intervention:
Biological: RSV-F Particle Vaccine

Phase:
Phase I

Study Type: Interventional

Study Design:

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment


Official Title:

A Phase 1 Randomized, Observer-Blinded,Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Recombinant Respiratory Syncytial Virus F Protein Particle Vaccine in Healthy Adults

Resource links provided by NLM:

MedlinePlus related topics: Respiratory Syncytial Virus Infections
U.S. FDA Resources

Further study details as provided by Novavax:

Primary Outcome Measures: •To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations. [ Time Frame: Day 60 (2 months) ] [ Designated as safety issue: Yes ]

This primary outcome will be evaluated through an assessment of the following parameters:
◦Immediate AEs
◦Solicited AEs
◦All SAEs and SNMCs
◦Vital signs
◦Laboratory Assessments

Secondary Outcome Measures: •To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations [ Time Frame: Day 60 (2 months) ] [ Designated as safety issue: No ]

This secondary outcome will be assessed in the following manner:
◦Neutralizing antibody against RSV measured in a PRNT assay
◦Total anti-F IgG measured by ELISA by ELISA


Enrollment:
150

Study Start Date:
December 2010

Study Completion Date:
December 2011

Primary Completion Date:
December 2011 (Final data collection date for primary outcome measure)

CONTINUED:
clinicaltrials.gov/ct2/show/NCT01290419


History of Changes and the ClinicalTrials.gov Archive Site

Information in a ClinicalTrials.gov record can be modified at any time by the data provider.

The display at ClinicalTrials.gov shows the most recent version for each data element.

The date first received and the date last updated are listed at the top of each record.

The full history of changes since the record was first received is available in the archival version of the record on the ClinicalTrials.gov Archive Site.

Current Study:

ClinicalTrials.gov Id:

NCT01290419

Study Title:

Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine

Continue to the history of changes for this study on the ClinicalTrials.gov Archive

Sitehttp://clinicaltrials.gov/archive/NCT01290419

First Received:

February 2, 2011

Last Updated:

March 6, 2012

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Articles citing this article

Viruslike Particle Vaccine Induces Protection Against Respiratory Syncytial Virus Infection in Mice The Journal of Infectious Disease October 2011 204:987-995


Assembly and Immunological Properties of Newcastle Disease Virus-Like Particles Containing the Respiratory Syncytial Virus F and G Proteins J. Virol. January 2011 85:366-377

Assembly and Biological and Immunological Properties of Newcastle Disease Virus-Like Particles J. Virol. May 2010 84:4513-4523

Assembly and Immunological Properties of Newcastle Disease Virus-Like Particles Containing the Respiratory Syncytial Virus F and G Proteins ▿

Lori W. McGinnes1,
Kathryn A. Gravel1,
Robert W. Finberg2,3,
Evelyn A. Kurt-Jones2,3,
Michael J. Massare4,
Gale Smith4,
Madelyn R. Schmidt1,2 and
Trudy G. Morrison1,2,*

+ Author Affiliations

1Department of Molecular Genetics and Microbiology

2Program in Immunology and Virology

3Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts

4Novavax, Inc., Rockville, Maryland

ABSTRACT

Human respiratory syncytial virus (RSV) is a serious respiratory pathogen in infants and young children as well as elderly and immunocompromised populations. However, no RSV vaccines are available. We have explored the potential of virus-like particles (VLPs) as an RSV vaccine candidate. VLPs composed entirely of RSV proteins were produced at levels inadequate for their preparation as immunogens. However, VLPs composed of the Newcastle disease virus (NDV) nucleocapsid and membrane proteins and chimera proteins containing the ectodomains of RSV F and G proteins fused to the transmembrane and cytoplasmic domains of NDV F and HN proteins, respectively, were quantitatively prepared from avian cells. Immunization of mice with these VLPs, without adjuvant, stimulated robust, anti-RSV F and G protein antibody responses. IgG2a/IgG1 ratios were very high, suggesting predominantly TH1 responses. In contrast to infectious RSV immunization, neutralization antibody titers were robust and stable for 4 months. Immunization with a single dose of VLPs resulted in the complete protection of mice from RSV replication in lungs. Upon RSV intranasal challenge of VLP-immunized mice, no enhanced lung pathology was observed, in contrast to the pathology observed in mice immunized with formalin-inactivated RSV. These results suggest that these VLPs are effective RSV vaccines in mice, in contrast to other nonreplicating RSV vaccine candidates.

Assembly and Biological and Immunological Properties of Newcastle Disease Virus-Like Particles▿

Lori W. McGinnes1,
Homer Pantua2,†,
Jason P. Laliberte2,‡,
Kathryn A. Gravel1,
Surbhi Jain1,§ and
Trudy G. Morrison1,2,*

+ Author Affiliations

1Department of Molecular Genetics and Microbiology


2Program in Immunology and Virology, University of Massachusetts Medical School, Worcester, Massachusetts

ABSTRACT

Virus-like particles (VLPs) released from avian cells expressing the Newcastle disease virus (NDV) strain AV proteins NP, M, HN (hemagglutinin-neuraminidase), and F were characterized. The VLP-associated HN and F glycoproteins directed the attachment of VLPs to cell surfaces and fusion of VLP membranes with red blood cell membranes, indicating that they were assembled into VLPs in an authentic conformation. These particles were quantitatively prepared and used as an immunogen, without adjuvant, in BALB/c mice. The resulting immune responses, detected by enzyme-linked immunosorbent assay (ELISA), virus neutralization, and intracellular cytokine staining, were comparable to the responses to equivalent amounts of inactivated NDV vaccine virus. HN and F proteins from another strain of NDV, strain B1, could be incorporated into these VLPs. Foreign peptides were incorporated into these VLPs when fused to the NP or HN protein. The ectodomain of a foreign glycoprotein, the Nipah virus G protein, fused to the NDV HN protein cytoplasmic and transmembrane domains was incorporated into ND VLPs. Thus, ND VLPs are a potential NDV vaccine candidate. They may also serve as a platform to construct vaccines for other pathogens.

FOOTNOTES
Received 11 September 2009.
Accepted 11 February 2010.

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Articles citing this article

Viruslike Particle Vaccine Induces Protection Against Respiratory Syncytial Virus Infection in Mice The Journal of Infectious Disease October 2011 204:987-995

Abstract
Full Text
PDF


Assembly and Immunological Properties of Newcastle Disease Virus-Like Particles Containing the Respiratory Syncytial Virus F and G Proteins J. Virol. January 2011 85:366-377

Abstract
Full Text
PDF


Assembly and Biological and Immunological Properties of Newcastle Disease Virus-Like Particles J. Virol. May 2010 84:4513-4523

Abstract
Full Text
PDF

jvi.asm.org/content/84/2/1110.abstract

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Recombinant nanoparticle RSV F vaccine for respiratory syncytial
virus: Preclinical efficacy and clinical safety and immunogenicity

RESEARCH POSTER PRESENTATION DESIGN 2011
www.PosterPresentations.com

Recombinant nanoparticle RSV F vaccine for respiratory syncytial virus: Preclinical efficacy and clinical safety and immunogenicity RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year.

In the United States RSV is the most common cause of bronchiolitis and pneumonia and hospitalization with 90,000 to 140,000 children < 1 year of age are hospitalized due to RSV infection. Up to 60 per 1,000 children <3 months are hospitalized annually. Similarly, an estimated 8.5 million adults, primarily the elderly, are infected with RSV resulting in 900,000 hospitalizations annually due to RSV in the United States and major European countries. In the United States alone there are 177,500 hospitalizations among high-risk adults resulting in annual medical costs exceeding $1 billion. There is
currently no approved vaccine for the prevention of RSV.

The RSV Fusion (F) surface glycoprotein protein is conserved across all strains and represents an important vaccine target. Synagis® (palivizumab) and Respigam® prophylactic antibodies target neutralizing epitopes on the F protein and have had a major impact on the RSV burden of disease in premature infants. The baculovirus/Sf9 insect cell system is conceptually ideal for the production of a surface glycoprotein vaccine antigen as the induction of a viral infection leads expression of the antigen via pathways designed to properly fold and produce antigen in its native configuration.

The RSV F nanoparticle vaccine is composed of full length F protein that is cleaved into disulfide linked F1 and F2 trimers which form highly stable 20-40 nm micelles due to the interaction of the hydrophobic regions via protein/protein interactions. In preclinical studies, the RSV F nanoparticle vaccine induces neutralizing antibodies and complete protection in challenge animals.

In this Phase 1 trial, the BV/Sf9 RSV F nanoparticle vaccine was evaluated in a dose escalation safety and immunogenicity trial. The immunogenicity evaluations including neutralization assays, ELISA against the native protein, ELISA and competitive ELISA against palivizumab epitopes, allow comparison of vaccine responses to naturally occurring protective antibodies and palivizumab and thus provide an estimation of the potential for efficacy as a prophylactic vaccine.


INTRODUCTION
CLINICAL SAFETY
IMMUNOGENICITY (contd.)
CONCLUSIONS
• The vaccine was well tolerated with the primary finding of mild local AEs and no dose effect • The vaccine was immunogenic inducing high titer antibodies that recognize the RSV F protein despite the presence of preexisting anti-F immunity
• High levels of seroconversion were observed including 100% in the high dose alum group
• A significant dose-response and alum effect was observed and a second dose appeared to further enhance the immune responses
• Antibodies that recognize the palivizumab epitope were increased over 20 fold and vaccine induced antibodies compete strongly with palivizumab
• PRNTs were significantly enhanced compared to placebo and reverse cumulative plots indicated that individuals with low titers were eliminated
• Post-immunization PRNTs in vaccine groups exceeded levels that have been estimated to be protective in the elderly, children and infants
• The RSV F recombinant nanoparticle vaccine appears to safely induce high levels of functional immunity and together the data indicate that this promising vaccine candidate should be further
developed,

1Novavax, 9920 Belward Campus Drive, Rockville MD 20850; 2Baylor College Of medicine, Department of Molecular Virology and Microbiology, and Pediatrics Houston Texas

Gregory Glenn1, Rama Raghunandan1, Hanxin Lu1, Bin Zhou1, Kwan Ngai1, Gulshan Dhariwal1, Eloi Kpamegan1, Michael J.
Massare1, Steven Pincus1, Lou Fries1, Piedra Pedro2, Letisha Aideyan2, Gale Smith1
www.novavax.com/download/file/presentations/RSV-F-Phase-1-Poster-2011_gs.pdf

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NOVAVAX to Present Results From Phase I RSV Study at XIV International Symposium on Respiratory Viral Infections

Press Release: Novavax, Inc. – Thu, Mar 22, 2012 9:52 AM EDT

ROCKVILLE, Md., March 22, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX - News) announced today that Louis F. Fries III, M.D., its Vice President, Clinical and Medical Affairs, will present results from the company's Phase I clinical trial of its recombinant nanoparticle vaccine candidate against respiratory syncytial virus (RSV) on March 24 and 26, 2012 at the XIV International Symposium on Respiratory Viral Infections in Istanbul, Turkey.

Dr. Fries will discuss results from the blinded, placebo-controlled, escalating-dose trial in separate poster and oral presentations at the conference. In October 2011, Novavax reported interim results from this trial which were consistent with preclinical studies and showed that the vaccine was well-tolerated, highly immunogenic and produced functional antibodies that neutralized RSV.

Dr. Fries stated: "These presentations provide Novavax with the opportunity to report on our Phase I safety and immunogenicity data to an audience of international experts in respiratory viral infections and vaccines. We will discuss the short-term and six month safety of the RSV nanoparticle vaccine in young adults. We will also describe the immunogenicity of our RSV vaccine, as measured by virus neutralization activity, and other immune evaluations that may be associated with protection against RSV. RSV is the most important viral respiratory disease of children globally and a cause of significant morbidity and mortality in the elderly. There is a clear need for an RSV vaccine for these age groups. The data from this trial are very encouraging, and suggest that the RSV nanoparticle vaccine has potential to elicit the level and type of immunity required to protect humans."

Later this year, Novavax expects to initiate two separate dose-ranging Phase II trials of its RSV vaccine candidate in the elderly and in women of child-bearing age. These separate trials will be conducted with, and without, an adjuvant and will provide both safety and immunogenicity results in these different age populations.

About Novavax

Novavax, Inc. (Nasdaq:NVAX - News) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website: www.novavax.com.

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THE CANADIAN PATENT OFFICE RECORD LA GAZETTE DU BUREAU DES BREVETS
Sylvain Laporte
Commissioner of Patents

The Canadian Patent Office Record is published on Tuesday of each week under the authority of the Commissioner of Patents, Ottawa-Gatineau, Canada, to whom all communications should be addressed.
The Canadian Intellectual Property Office does not guarantee the accuracy of this publication, nor under¬take any responsibility for errors or omissions or their consequences.

Sylvain Laporte
Commissaire aux brevets

www.ic.gc.ca/cipo/patgazarc.nsf/v_arcedition_e/08-23-2011cpor/$File/cpor.pdf?OpenElement


Vol. 139 No. 34 August 23 août 2011 178

NOVAVAX - 2,746,228

Demandes PCT entrant en phase nationale

91 Vol. 139 No. 34 August 23 août 2011 [21] 2,746,228 [13] A1 [51] Int.Cl. A61K 39/155 (2006.01) [25] EN [54] MODIFIED RSV F PROTEINS AND METHODS OF THEIR USE [54] PROTEINES F DE VRS MODIFIEES ET LEURS METHODES D’UTILISATION [72] SMITH, GALE, US

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From the conferenceCall :

"PATH is NOT the only partner Novavax will take on...Ercks remarks within the release....

"This partnership with PATH complements our corporate strategy to:

1. "develop this RSV vaccine for multiple indications in affected patient populations" ...

2. "in all markets throughout the world" ...

3. "with multiple partners."

As several have pointed out, the price of admission to discussions with Novavax on RSV has gone up!

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From the Q2 call specifically related to RSV:

"As we said in the past, and first of all, I don't predict timing of partnering of our programs with pharmaceutical companies. As everybody knows, these are long discussions, data has to be exchanged, there's lots of back-and-forth and the timing of these partnerships are completely unpredictable. So I won't predict.

We are talking to ALL of the interested parties....

So we're talking to all of the interested parties and our goal would be, ultimately, to find a partner who could finance the later stage Phase IIs and Phase IIIs for this program. And whether it's on a regional basis or global basis, that will be negotiated. And what residual rights we have depends precisely on those negotiations.

We are starting into Phase II clinical trials on our own. How much further we go depends upon the partner....

We currently have the capability to manufacture sufficient material and sufficient quantities to launch a product. And we have the infrastructure both clinically and regulatory to take it through licensure with what would be an expanded group if we're funded to do that. So I think again it's a negotiation. We're taking it through the manufacturing process and starting into Phase II clinical trials on our own. And how much further we go depends upon the partner."

[tyfighter3]

It looks like they started thier Phase 2 trials on RSV vaccine. I hope that it all goes well. Looks like a money maker.

[dothedd]

HI Ty,

Yes, I saw that when it came out ... just haven't time to post it, but thanks for reminding me.

There are LOTS OF MONEY MAKERS in the pipeline... what we need is FDA approval to take IT to the BANK!

barb

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Novavax Initiates Phase 2 Clinical Trial of RSV Vaccine Candidate

Rockville, MD (October 8, 2012)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today announced that enrollment has begun in a Phase 2 dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age. The study is being conducted in collaboration with PATH, an international nonprofit organization that transforms global health through innovation, which is providing approximately $2 million in funding to support the trial.

This randomized, blinded, placebo-controlled Phase 2 study will evaluate the immunogenicity and safety of two dose levels of Novavax’s RSV-F protein nanoparticle vaccine with and without aluminum phosphate as an adjuvant. The study will enroll 330 women of childbearing age who will receive either one or two intramuscular injections at each dose level of vaccine or placebo at days 0 and 28. Safety and immunogenicity will be evaluated over six and four month periods, respectively.

“In addition to evaluating the safety and immunogenicity of our RSV vaccine candidate in an important patient population, this study will be crucial for both the determination of the optimal dosing regimen for future studies and the potential adjuvant effect of aluminum phosphate, an adjuvant used in U.S. licensed products,” said Gregory Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax. “Previous clinical and preclinical findings have suggested that immunization with our nanoparticle vaccine produces functional neutralizing antibodies to multiple sites on the F protein. We expect to report top-line results from this trial, through Day 56 observations, in the first quarter of 2013.”

About RSV and Maternal Immunization

RSV is the most common cause of childhood respiratory infection globally, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease necessitates 3.4 million hospital admissions per year and disproportionately affects infants below six (6) months of age. A severe episode of RSV bronchiolitis can lead to recurrent bouts of reactive airway disease/asthma for many years after the initial event. It is a highly contagious virus that occurs as a predictable epidemic from late autumn through early spring in the U.S. and other northern hemisphere regions and can have more than two annual peaks in tropical climates. RSV disease burden in low-resource countries is significant, and available data indicate that the virus is responsible for a high proportion of childhood acute lower respiratory infection in these settings, particularly in the first few months of life. Currently, there is no approved RSV prophylactic vaccine available. Maternal immunization is a widely practiced strategy for protecting infants in a variety of diseases, such as neonatal tetanus and is currently recommended by the Center for Disease Control’s Advisory Committee on Immunization Practices for battling infant pertussis. Maternal immunization can lead to heightened antibodies in infants and thereby protects them against the targeted disease, and thus may be a key strategy to protect young infants from RSV illness.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax’s worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company’s website, www.novavax.com.

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Novavax Reports Progress on RSVVaccine at the XV International Symposium on Respiratory Viral Infections

(Ref:GlobeNewswire)

March18th, 2013

ROCKVILLE, Md. (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) reported that David C. Flyer, Ph.D., Director of Preclinical Development at Novavax, presented recent preclinical findings from the company's respiratory syncytial virus (RSV) vaccine development program at the XV International Symposium on Respiratory Viral Infections in Rotterdam, the Netherlands. He reported that in preclinical studies, Novavax' RSV vaccine candidate induced anti-RSV antibodies capable of neutralizing RSV in vitro and significantly reduced infectious RSV in a cotton rat challenge model. Further, in both clinical and preclinical studies, he reported that palivizumab-competing antibodies were generated at titers significantly above that found to be protective in both humans and cottons rats
.

Dr. Flyer stated during his presentation: "Both the human and cotton rat data suggest that our RSV vaccine candidate induced robust antibody responses with activity similar to palivizumab, which is a licensed anti-RSV monoclonal antibody indicated for the prevention of RSV disease in at-risk children and infants. These data provide further scientific evidence that our vaccine candidate may have the potential to safely protect infants in the first few months of life, where morbidity and mortality from RSV is greatest, as well as other affected populations including pediatric and elderly patients."

In October 2012, the company initiated two separate dose-ranging clinical trials, one in women of child bearing age and the other in elderly adults. The first trial is a randomized, blinded, placebo-controlled Phase II clinical trial evaluating the safety and immunogenicity of two dose levels of the RSV vaccine candidate with and without an aluminum phosphate adjuvant, with 330 women of childbearing age enrolled. Top-line data from this trial are expected to be announced in April 2013. The second trial is a randomized, blinded, placebo-controlled Phase I clinical trial evaluating the safety and immunogenicity of two doses of the RSV vaccine candidate, also with and without aluminum phosphate as an adjuvant, with 220 elderly adults enrolled. Top-line data from this trial are expected to be reported later in the second quarter of 2013.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com

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Novavax Reports Positive Top-Line Results From Phase II Clinical Trial of RSV Vaccine Candidate in Women of Childbearing Age

·       Well-tolerated and without any vaccine relatedserious adverse events (SAEs)

·       Anti-F IgG antibodies to the F protein inserum rose 6 to 16-fold across all doses (60 and 90 µg). Addition of adjuvantenhanced response with both first and second vaccinations

·       Neutralizing antibody responses were seen withboth doses and with a similar magnitude following first or second vaccinations

·       Data provides basis for ongoing development ofan RSV vaccine

·       Conference call/webcast Wednesday, April 3rdat 10:00 am EDT

• Conference call/webcast Wednesday, April 3^rd at 10:00 am EDT

ROCKVILLE, Md., April 2, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that top-line data from the Phase II dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age accomplished the trial's protocol-specified objectives and supports progression to the next stage of advanced clinical testing. The trial represents an important step towards establishing the safety and immunogenicity of the vaccine candidate for use in a maternal immunization strategy. In such a strategy, the antibodies in vaccinated women can be expected to be naturally transferred to their infants in utero and thereby may confer passive protection at the earliest stage of life when these infants are extremely vulnerable to severe respiratory disease due to RSV.

This randomized, blinded, placebo-controlled Phase II clinical trial evaluated the safety and immunogenicity of two-dose levels of Novavax' RSV F protein nanoparticle vaccine candidate with and without aluminum phosphate (alum) as an adjuvant. The study enrolled 330 women of childbearing age who received either one or two intramuscular injections of a single-dose of vaccine or placebo, at study day 0 and day 28. Doses of 60 and 90 µg were tested, either with or without alum as an adjuvant. Safety and immunogenicity data for this clinical trial have been evaluated through day 56. Safety will continue to be evaluated over a total period of six months and immunogenicity for four months for each participant. The clinical trial is being conducted in collaboration with PATH, an international nonprofit organization that transforms global health through innovation. PATH committed funding of approximately $2 million to support this trial with the aim of advancing the development of an RSV vaccine to protect infants through maternal immunization in low-resource countries.

In this trial, the vaccine candidate was generally well-tolerated and the safety profile was similar to that observed previously in the Phase I clinical trial. The principal observation was transient mild to moderate injection site pain, predictably somewhat more frequent in the adjuvanted vaccine recipients. There were no clinically important differences in systemic adverse events between placebo and active vaccine recipients and no vaccine related SAEs. The most commonly reported systemic reactogenicity was comprised mainly of mild to moderate headache, fatigue and muscle ache, which are frequently noted after treatment by many vaccines. There were no differences in safety assessments across doses (60 and 90 µg) or worsening of reactogenicity with a second-dose. Laboratory testing did not reveal clinically significant changes in normal blood chemistries or hematology parameters.

The primary objectives of the study measured the difference in anti-F IgG elicited by the use of alum adjuvant, one versus two immunizations, and across doses (60 and 90 µg). The use of alum enhanced both the single and two-dose regimen anti-F IgG responses, with the greatest responses observed using a two-dose regimen. Peak geometric mean titers of anti-F IgG in the two-dose alum groups ranged from 12,000-14,000 representing a 13 to 16-fold rise, compared to a 6 to 10-fold rise in the non-alum groups. Minimal increases were observed by increasing the doses (60 to 90 µg). Peak geometric mean RSV A neutralizing antibodies in the alum groups ranged from log₂ 9.5-10.5, representing a 3.1 to 3.8-fold rise. Palivizumab-like antibody titers rose 8 to 9-fold, with four-fold rises in ≥92% of vaccinees in the two-dose alum adjuvanted vaccine groups. Overall, the immune responses observed in this Phase II clinical trial were similar to, or exceeded immune responses seen in the Phase I clinical trial using the Novavax nanoparticle vaccine.

"These results confirm that our RSV vaccine candidate has the potential to induce clinically useful immunity and has raised no safety concerns. The primary immunogenicity measures confirmed that the vaccine is a potent antigen and the aluminum phosphate adjuvant further enhanced the antibody responses. The results answered key questions regarding dose regimens and the use of aluminum phosphate as adjuvant," said Gregory Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax. "With respect to secondary and exploratory objectives, we also observed that the vaccine induced peak neutralizing antibodies in excess of those seen in our Phase I trial, as well as reproducing palivizumab-like antibody responses. Neutralizing antibodies have been associated with decreased risk of hospitalization in infants and palivizumab is a licensed monoclonal antibody, marketed as Synagis®, that is used to prevent high-risk infant hospitalization due to RSV. The findings from this clinical trial indicate that our RSV F vaccine candidate has the potential to induce functional immune responses at levels that would be predicted to protect infants through maternal immunization. Overall, we are buoyed by these data and believe these findings warrant the pursuit of later-stage clinical trials."

Webcast and Conference Call

An audio webcast and conference call will be held with Novavax' senior management to discuss the results on April 3, 2013 at 10:00am EDT and available at www.novavax.com under Investor Info/Events. The dial-in number for the conference call is 1 [phone] (U.S. or Canada) or 1 [phone] (International). Webcast and telephone replays of the conference call will be available shortly after the completion of the call. To access the replay by telephone, dial 1 [phone] (Domestic) or 1 [phone] (International) and use passcode 30243955.

About RSV and Maternal Immunization

Maternal immunization is a strategy which can be used to protect infants from a variety of infectious diseases in the first months of life if enough protective antibodies can be transferred from mother to child. It is currently recommended by the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices for battling infant pertussis disease (whooping cough). Vaccine-induced maternal antibodies cross the placenta and often achieve concentrations in the fetus in excess of those seen in maternal sera. These naturally transferred antibodies are known to provide protection to the infant against many infectious diseases based on the exposure history of the mother, including protection against RSV in the first weeks of life. As the maternally derived antibody titers drop over time, infants become more susceptible to RSV disease. Maternal immunization for RSV is a potential clinical strategy aimed at boosting the level of antibodies transferred to infants and thereby extending the period over which they are protected. Field studies indicate that high concentrations of antibody in mothers due to natural exposure is correlated with lower RSV infection rates in newborns. RSV is the leading cause of hospitalization in the first months of life, an age at which implementation of complete active (direct) immunization is generally considered unlikely to succeed. More than half of US RSV related hospitalizations occur in infants three months of age and under. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and causing approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. A severe episode of RSV bronchiolitis can lead to recurrent bouts of reactive airway disease/asthma for many years after the initial event. RSV is a highly contagious virus that occurs as a predictable epidemic from late autumn through early spring in the US and other northern hemisphere regions, and can have two annual peaks or more in tropical climates. RSV disease burden in low-resource countries is significant, and available data indicate that the virus is responsible for a high proportion of childhood acute lower respiratory infection in these settings, particularly in the first few months of life. Currently, there is no approved RSV prophylactic vaccine available.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platform to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.

About PATH

PATH is an international nonprofit organization that transforms global health through innovation. PATH takes an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving vaccines and devices to collaborative programs with communities. Through its work in more than 70 countries, PATH and its partners empower people to achieve their full potential. For more information, visit www.path.org.

[dothedd]

 (Novavax (Novavax to Review Recent Findings from Vaccine Programs at World Vaccine Congress and Expo in Washington to Re (Novavax to Review Recent Findings from Vaccine

ROCKVILLE, Apr 15, 2013 (GLOBE NEWSWIRE via COMTEX) -- Novavax, Inc.
(Nasdaq:NVAX) announced today that it will review recent clinical results from
the company's vaccine development programs at the World Vaccine Congress and
Expo this week in Washington, DC.

On April 16 at 5:55pm (ET) during the session on prophylactic vaccines, Dr.
Gregory Glenn, Novavax' Senior Vice President and Chief Medical Officer, will
discuss results from the company's respiratory syncytial virus (RSV)
nanoparticle vaccine development program, including recently announced positive
results from a Phase II clinical trial in women of childbearing age. In that
trial, Novavax' vaccine candidate was well-tolerated and demonstrated sufficient
immunogenicity with and without aluminum phosphate as an adjuvant to support
plans for later-stage clinical testing. The company believes its RSV vaccine
candidate has the potential to induce functional immune responses at levels that
may protect infants through maternal immunization.

On April 17 at noon (ET) during the session on influenza vaccines, Dr. Louis
Fries, Novavax' Vice President, Clinical and Medical Affairs, will review
results from the company's virus-like particle pandemic H5N1 influenza vaccine
clinical program. In a recent Phase I clinical trial, Novavax' vaccine candidate
was well-tolerated and demonstrated sufficient immunogenicity at multiple dose
levels with and without an adjuvant to support advancement into Phase II
testing. The company believes its Phase I findings suggest that the adjuvanted
vaccine candidate could provide antigen dose sparing and strong immune responses
to the targeted virus.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company
creating vaccines to address a broad range of infectious diseases worldwide.
Using innovative recombinant nanoparticle technology, as well as new and
efficient manufacturing approaches, the company produces vaccine candidates to
combat diseases, with the goal of allowing countries to better prepare for and
more effectively respond to rapidly spreading infections. Novavax is committed
to using its technology platform to create geographic-specific vaccine solutions
and is therefore involved in several international partnerships, including
collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea
and PATH. Together, these organizations support Novavax' worldwide
commercialization strategy and have the global reach to create real and lasting
change in the biopharmaceutical field. Additional information about Novavax is
available on the company's website, www.novavax.com.</a></font>

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RSV vaccine trial in pregnant women 

WHO site list research done on sub unit profusion F vaccine back in 2003. Work was done by Baylor U. The antigen was produced by Wyeth. So they already know that babies will get some level of protection. Explains why the PATH moved on it.

Geometric mean concentrations of IgG ELISA Ab were 4 fold higher in infants of vaccine recipients at birth, 2 and 6 months after delivery than in infants of placebo recipients (P or =3 weeks. There was no evidence of enhanced T-cell or cytokine activity in infants of vaccine recipients vs. infants of placebo recipients. Vaccine specific anti-F IgA and IgG concentrations in breast milk were higher in mothers who received RSV-PFP-2.

A modest (0.5log2) increase in neutralization Ab was observed in vaccine recipients and their infants.

"Novavax figured out how to greatly increase the neutralizing antibody (snyergis). I think that is the key difference here. Not really sure though. I'm just an avg investor trying to be a biologist. You pretty much have to if you want to invests in Novavax. The science is solid. RSV is multi billion market and NVAX is out in front. Fidelity and RA bought because of RSV. They know how big it is. 

Looks like NVAX has continued the work with better technology creating the neutralizing antibodies that the Baylor trial missed on. Baylor is involved in our trials as well. I wonder if the patent fees that NVAX has to pay to Wyeth has to do with this. Pfizer would be likely candidate to partner or acquire. They could use a Flu platform as well. They could through one quarter of cash dividend at this deal and we would all be very happy."

NOVAVAX   

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Novavax: Big Pharma Wants RSV Bad
Aug 18 2013, 07:40
In my last article on Novavax Inc. (NVAX), I pointed readers toward a coming catalyst in the stock that didn't present itself on the FDA calendar but rather on Novavax's own schedule: the 1st Annual Analyst Day to be held September 24, 2013.

While I had hoped this might be a presentation fast tracking Novavax's RSV-F vaccine, their Wedbush presentation on August 14 ruled out that possibility - at least in two of the three population groups - RSV in the elderly remains a fast-track possibility. Then came Lazard.

On August 15th, Lazard Capital Markets through analyst William Tanner who was quoted in my article reiterated their buy position and raised the target price to $11 from $4.

Question: What caused their reappraisal of Novavax's worth? Answer: Their reassessment of the value of Novavax RSV-F vaccine.

In Lazard's own words through the aforementioned William Tanner:

Novavax RSV-F vaccine is potentially one of the most under appreciated assets in the industry.

While that may be true for industry leaders and the larger investing public outside of Seeking Alpha, it hasn't been true for readers here who have been apprised of the enormous potential value of this asset in several stories including my last two iterations providing RSV insights.

Big pharma has been trying for years to perfect an RSV vaccine but with no success. You can see some of the big names who have thrown up their hands in frustration including Novartis and Merck from the graphic below provided by Novavax' partner, PATH.
static.cdn-seekingalpha.com/uploads/2013/8/16/4021161-13766531509687326-Michael-Webb_origin.png        

Suffice it to say that RSV-F enters a field of preventative care all to itself with a comparator in Pfizer's Prevnar 13 that rakes in a cool $3.7B a year. Though RSV-F is several years away from commercialization its Phase 1 & 2 trial results thus far have been outstanding.

Some other items you may or may not be aware of with respect to Novavax' RSV-F are as follows.

RSV-F vaccine creates Palivizumab equivalent antibodies in host individuals. Palivizumab is the active antigen in Medimmune's Synagis a $1B per year RSV drug used predominantly in premature infants whose exposure to RSV is extremely life threatening.
Novavax staff is increasingly composed of former Medimmune personnel including its former president of 20 years - James Young.
Here is President and CEO Stanley Erck speaking at the Wedbush Conference this past Wednesday.

"I think we have really benefited from what Medimmune did in measuring the amount of antibody that's required."

"So I'm the CEO. I brought on as chairman Jim Young who's the founder of Medimmune, was president of Medimmune for twenty years, R& for twenty years - and we have probably a third of our company is ex-Medimmune people. So, we have a lot of depth in the company in terms of RSV knowledge."

The Phase 2a trial now completed in women of childbearing age revealed Palivizumab equivalent antibodies that were 10x what Medimmune determined to be immunogenic at both dose levels, with or without adjuvant.
static.cdn-seekingalpha.com/uploads/2013/8/16/4021161-13766489024976258-Michael-Webb_origin.png

The following is a calendar of upcoming RSV-F events drawn from a slide presented at the Wedbush conference referenced above.
static.cdn-seekingalpha.com/uploads/2013/8/16/4021161-13766501009229486-Michael-Webb_origin.png
 
As you can see, RSV-F development will contribute to a host of events that will catalyze the stock over the coming several months. That said, we don't necessarily see the explosive event I referred to in my last article.

So, am I willing to throw in the towel on rapid appreciation in advance of September 24th? Hardly! Since my article was published after market close on August 13th, we've already seen the stock climb 13.9%. Lazard's endorsement alone raised in 7.57% in a single day.

As I established in that article, September 24th is a unique event in the history of the company since its reformulation as a vaccine maker in 2005. The day could be a mere formality but the stage suggests it isn't. The inaugural incidence of an annual occurrence rarely is - think weddings and the like. It was William Tanner himself of Lazard Capital Markets that didn't want to "jump the gun" on just what was to be revealed on this special day.

As a result, I'm led to believe there's a surprise coming on September 24th and it will contribute to the value of this company and growth of this stock. In the interim, we'll be left to speculate on just what that might be.

Be aware that fast track status for RSV in the elderly remains a distinct possibility, albeit not a strong one. Novavax' Quadrivalent seasonal flu vaccine has passed Phase II with efficacy in all four strains. It was noticeably absent from the discussion of being modified with the new Matrix-M adjuvant acquired from Isconova that will be applied to the pandemic mixture.

This is important because Novavax established in its Phase 1 trial in RSV in the elderly that its RSV-F vaccine had no deleterious effect on the performance of an established flu vaccine and has since indicated it will market both together in one formulation.

Therefore, fast track status for RSV-F in the elderly population cannot be ruled out as a possible announcement on September 24th. I also want to establish here and now that fast track status for RSV in the remaining two populations - infants and women of childbearing age - remains an open possibility down the line just not within the time frame specified here.

Other possibilities include enhancement of the government's contribution to the pandemic program. BARDA has already committed to seeing both influenza programs through to licensure in terms of reimbursement of all trial costs. Perhaps they'll offer to do more in light of the phenomenal speed and efficacy demonstrated by Novavax in their H7N9 development that occurred in a record 91 days.
static.cdn-seekingalpha.com/uploads/2013/8/16/4021161-13766462440713856-Michael-Webb_origin.png

Bill and Melinda Gates, through PATH, have generously supported RSV-F in women of childbearing age. Perhaps they've offered additional support as the program advances toward completion.

And then in addition to tamping out the fire of fast track status for RSV in the infant and women of childbearing age populations at Wedbush, Stanley Erck stirred the brewing pot of investor interest speaking for the first time in my memory of partnership discussions that included marketing territories for its entire pipeline of drug candidates.

The possibilities are as numerous and varied as Novavax's growing list of institutional supporters that include...

Institution # of Shares Market Value
Vanguard 4.15M $9.47M
Ayer Capital Mgmt 2.77M $5.24M
State Street Corp 1.99M $4.54M
Abingworth 1.50M $1.91M
Ironwood Investment 1.49M $1.87M

There were 21 more on that list including such brick and mortar staples as Charles Schwab, RA Capital Management and Goldman Sachs.

Oh, and try not to forget the Stifel Nicolaus Healthcare Conference on September 11th and 12th where President Erck will once again take the podium and move our imagination.

In conclusion, this article and the previous two pointed to a bright future for Novavax and indicated that the company was extremely undervalued. This past week, William Tanner of Lazard Capital Markets agreed with that position.

It's always satisfying to have one's work validated by so-called "experts" but investment in this sector carries considerable risk regardless.

Please, consult a financial advisor before making any investment decision and always be well.

Source: Novavax: Big Pharma Wants RSV Bad
Additional disclosure: The purpose of my article is to provide information the accuracy of which is as good as the public sources it was derived from. If providing my opinions on matters related to any investment has entertained you then I have accomplished my only goal. Do not act on anything I have written. Rather, do your own due diligence and consult an investment professional before making any investment decision. Acting on what any one writer, including me has imparted to you is foolish at best. I have no better access to resources or gift of opinion formulation than you do. There are a myriad of things which can happen in lieu of any forward looking statement I have made. Any stock featured in an article I compose is subject to all manner of influences which can change its value in dramatic fashion upwards or downwards. Invest at your own risk and attain the reward your efforts have wrought.

[dothedd]

Clinical Research Atlanta Trial Study
RSV vaccine (Novavax)

October 07
2013

September 03
2014
Target Audience:
Health women between 18 and 36 years of age.
Payment:
Up to $740 for time and travel.
This study is for an investigational vaccine for Respiratory Syncytial Virus (RSV). For more information on RSV please see article on WebMD.
Study has 9 office visits over 6 months.

clinicalresearchatlanta.com/trials/view/40
 

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Novavax Initiates Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate
Mon Oct 7, 2013 4:35pm EDT

ROCKVILLE, Md., Oct. 7, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that enrollment has begun in a Phase 2 dose-confirmatory clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age.

This randomized, blinded, placebo-controlled Phase 2 study will evaluate the immunogenicity and safety of multiple formulations of Novavax' RSV-F protein nanoparticle vaccine candidate with aluminum phosphate as an adjuvant. The study is scheduled to enroll 720 women of childbearing age who will receive either one or two intramuscular injections at each dose level of vaccine or placebo at days 0 and 28. Immunogenicity and safety will be evaluated over three month and six month periods, respectively.

"This trial represents important progress for our RSV vaccine, which is being developed to protect young infants through maternal immunization," said Gregory Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax. "This study will help define the dose and dose regimen and expand the safety database for our maternal immunization strategy. These are all essential steps in the advancement of this important vaccine towards licensure."

About RSV

RSV is a respiratory pathogen that afflicts all humans regardless of age. In healthy adults, RSV infections are generally mild to moderate in severity, but may be more severe in infants and young children as well as the elderly and adults with underlying chronic cardiac or pulmonary disease. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. It is estimated that between 11,000 to 17,000 elderly and high risk adults die of RSV infection annually in the U.S., with up to 180,000 hospitalizations for serious respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine available for either of these populations.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces information about Novavax is available on the company's website, novavax.com.vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. 

Additional information about Novavax is available on the company's website, novavax.com.

[dothedd]

UPDATE: Novavax (NVAX) Target Raised to $12 at Wedbush; Analyst Expects Positive Data on RSV-F Vaccine

(Updated - December 16, 2013 11:16 AM EST)

Wedbush maintained an Outperform rating on Novavax (NASDAQ: NVAX) and raised its price target to $12.00 (from $4.00).

Analyst Gregory R. Wade said, "Based on our expectation for continuing positive data for the RSV-F vaccine product candidate, and revised expectations on the format of an RSV-F vaccine product (RSV/flu combination), we are both reformatting and revising our financial projections for NVAX and now include future potential sales of an RSV-F combination product in our expectations.

"We believe combination RSV-F vaccine will be a highly successful product in the pregnant female (3.2/3.9M per year US/EU), infant (3.2/3.9M per year) and elderly (39.5/61.6M) market segments based upon the potential for maternal immunization to protect newborns from one of the leading causes of hospitalization (RSV infection) and potential to reduce the impact of seasonal upper respiratory infections that frequently lead to hospitalization in the elderly," continued Wade.

"We now project NVAX will launch a combination RSV-F vaccine in H2:18 and H2:19 in the US and Europe, respectively, and that sales will reach nearly $1 billion by 2020."

For an analyst ratings summary and ratings history on Novavax click here. For more ratings news on Novavax click here.

Shares of Novavax closed at $3.87 yesterday, with a 52 week range of $1.68-$4.34.

www.streetinsider.com/Analyst+Comments/UPDATE:+Novavax+(NVAX)+Target+Raised+to+$12+at+Wedb
ush;+Analyst+Expects+Positive+Data+on+RSV-F+Vaccine/8981259.html

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RSV F Dose-Ranging Study in Women
This study is ongoing, but not recruiting participants.
Sponsor:
Novavax
Information provided by (Responsible Party):
Novavax

ClinicalTrials.gov Identifier:
NCT01960686
First received: October 8, 2013
Last updated: October 18, 2013
Last verified: October 2013

Purpose
The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age.

Condition Intervention Phase
Respiratory Syncytial Virus Infections
Biological: Low dose RSV F Antigen
Biological: High dose RSV F Antigen
Biological: Dose 1 of Adjuvant
Biological: Dose 2 of Adjuvant
Biological: Dose 3 of Adjuvant
Biological: Dose 4 of Adjuvant
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Multiple Formulations of an RSV F Particle Vaccine With Aluminum, in Healthy Women of Child-Bearing Age

Resource links provided by NLM:

MedlinePlus related topics: Respiratory Syncytial Virus Infections
Drug Information available for: Aluminum
U.S. FDA Resources

Further study details as provided by Novavax:

Primary Outcome Measures:
Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups [ Time Frame: Day 0 to Day 56 ] [ Designated as safety issue: No ]
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. Derived/calculated endpoints based on these data will include:
Geometric mean concentrations as EU (GMEU)
Geometric mean ratio (GMR)
Geometric mean fold-rise (GMFR)
Seroconversion rate (SCR)
Seroresponse rate (SRR)

Assessment of Safety [ Time Frame: Day 0 to Day 182 ] [ Designated as safety issue: Yes ]
Numbers and percentages of subjects with solicited local and systemic adverse events over the seven days post-injection; and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters. In addition, Medically Attended Events, Serious Adverse Events, and Significant New Medical Conditions will be collected for six months.


Secondary Outcome Measures:
Immunogenicity based on neutralizing antibody titer [ Time Frame: Day 0 to Day 56 ] [ Designated as safety issue: No ]
Kinetics of serum IgG antibody titers specific for the F-Protein antigen across time [ Time Frame: Day 0 to Day 91 ] [ Designated as safety issue: No ]
Immunogenicity based on antibodies sharing specificity with Palivizumab [ Time Frame: Day 0 to 91 ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: October 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose RSV F Vaccine with Dose 1 of Adjuvant
Day 0: Low dose RSV F Antigen with Dose 1 of aluminum adjuvant Day 28: Placebo
Biological: Low dose RSV F Antigen Biological: Dose 1 of Adjuvant Biological: Placebo
Experimental: Low dose RSV F Vaccine with Dose 2 of Adjuvant
Day 0: Low dose RSV F Antigen content with Dose 2 of aluminum adjuvant Day 28: Low dose RSV F Antigen content with Dose 2 of aluminum adjuvant
Biological: Low dose RSV F Antigen Biological: Dose 2 of Adjuvant
Experimental: Low dose RSV F Vaccine with Dose 3 of Adjuvant
Day 0: Low dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Low dose RSV F Antigen with Dose 3 of aluminum adjuvant
Biological: Low dose RSV F Antigen Biological: Dose 3 of Adjuvant
Experimental: Low dose RSV F Vaccine with Dose 4 of Adjuvant
Day 0: Low dose RSV F Antigen with Dose 4 of aluminum adjuvant Day 28: Low dose RSV F Antigen with Dose 4 of aluminum adjuvant
Biological: Low dose RSV F Antigen Biological: Dose 4 of Adjuvant
Experimental: High dose RSV F Vaccine with Dose 2 of Adjuvant
Day 0: High dose RSV F Antigen with Dose 2 of aluminum adjuvant Day 28: Placebo
Biological: High dose RSV F Antigen Biological: Dose 2 of Adjuvant Biological: Placebo
Experimental: High dose RSV F Vaccine with Dose 3 of Adjuvant
Day 0: High dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Placebo
Biological: High dose RSV F Antigen Biological: Dose 3 of Adjuvant Biological: Placebo
Experimental: High dose RSV F Vaccine with Dose 4 of Adjuvant
Day 0: High dose RSV F Antigen content with Dose 4 of aluminum adjuvant Day 28: Placebo
Biological: High dose RSV F Antigen Biological: Dose 4 of Adjuvant Biological: Placebo
Placebo Comparator: Placebo
Day 0: Placebo Day 28: Placebo
Biological: Placebo

Eligibility

Ages Eligible for Study: 18 Years to 35 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:

Subjects must meet the following criteria to be eligible to participate:

Healthy adult females, ≥ 18 and ≤ 35 years of age. "Healthy" shall be defined by the absence of any illness, acute or chronic, that requires ongoing systemic therapy for the control of symptoms or prevention of disability.
Subjects on stable (no change in ≥ 3 months) therapy for findings (e.g., hypertension or hyperlipidemia) that are not associated with symptoms or disability are eligible, as are users of hormonal contraceptives.
Subjects who receive intermittent prophylaxis for risks associated with asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures in a subject with mitral valve prolapse) are eligible.
Ongoing therapy will be defined as continuous or, if intermittent, more frequent than once every 3 months (e.g., use of an inhaled bronchodilator for exercise-induced bronchospasm more than once every 3 months). Immunosuppressives are subject to exclusion criterion #5 below.
Persons being treated for illnesses or conditions that would become acutely symptomatic or disabling in the absence of treatment are not eligible.
Willing and able to give informed consent prior to study enrollment.
Able to comply with study requirements.
Women who are not surgically sterile must have a negative urine pregnancy test prior to each vaccination; will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.
Exclusion Criteria:

Subjects will be excluded if they fulfill any of the following criteria:

Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
History of a serious reaction to any prior vaccination.
Received any vaccine in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time.
Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
Donated blood within 3 weeks of the planned date of first vaccination.
Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration).
Known disturbance of coagulation.
Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01960686

Locations
United States, California
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Georgia
Clincal Research of Atlanta
Stockbridge, Georgia, United States, 30281
United States, Idaho
Advanced Clinical Research
Boise, Idaho, United States, 83642
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
United States, Missouri
QPS Bio-Kinetic
Springfield, Missouri, United States, 65802
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, South Carolina
Coastal Carolina Research
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Novavax
Investigators
Study Director: D. Nigel Thomas, Ph.D. Novavax, Inc.

CONTINUED:
clinicaltrials.gov/ct2/show/study/NCT01960686?term=novavax

[dothedd]

Signs and symptoms


The incubation time (from infection until symptoms arrive) is 4–5 days.For adults, RSV produces mainly mild symptoms, often indistinguishable from common colds and minor illnesses. The Centers for Disease Control consider RSV to be the "most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States".[3]For some children, RSV can cause bronchiolitis, leading to severe respiratory illness requiring hospitalization and, rarely, causing death. This is more likely to occur in patients that are immunocompromised or infants born prematurely. Other RSV symptom

Recurrent wheezing and asthma are more common among individuals who suffered severe RSV infection during the first few months of life than among controls;[5] whether RSV infection sets up a process that leads to recurrent wheezing or whether those already predisposed to asthma are more likely to become severely ill with RSV has yet to be determined.

Symptoms of pneumonia in immuno-compromised patients such as in transplant patients and especially bone marrow transplant patients should be evaluated to rule out RSV infection. This can be done by means of PCR testing for RSV nucleic acids in peripheral blood samples if all other infectious processes have been ruled out or if it is highly suspicious for RSV such as a recent exposure to a known source of RSV infection.

In at least one case, RSV onset appears to have coincided with the onset of type 2 diabetes, and there may be a possible correlation.[6][7]
Virology

Genome

The genome is ~15,000 nucleotides in length and is composed of a single strand of RNA with negative polarity. It has 10 genes encoding 11 proteins—there are 2 open reading frames of M2. The genome is transcribed sequentially from NS1 to L with reduction in expression levels along its length.
NS1 and NS2 inhibit type I interferon activity.

Transmission

RSV spreads easily by direct contact, and can remain viable for a half an hour or more on hands or for up to 5 hours on countertops.[11] Childcare facilities allow for rapid child-to-child transmission in a short period of time.[12]

Prevention

As the virus is ubiquitous in all parts of the world, avoidance of infection is not possible. A vaccine trial in 1960s using a formalin-inactivated vaccine (FI-RSV), increased disease severity in children who had been vaccinated.[13] There is much active investigation into the development of a new vaccine, but at present no vaccine exists. Some of the most promising candidates are based on temperature sensitive mutants which have targeted genetic mutations to reduce virulence.

However, palivizumab (brand name Synagis manufactured by MedImmune), a moderately effective prophylactic drug is available for infants at high risk. Palivizumab is a monoclonal antibody directed against RSV surface fusion protein. It is given by monthly injections, which are begun just prior to the RSV season and are usually continued for five months. RSV prophylaxis is indicated for infants that are premature or have either cardiac or lung disease, but the cost of prevention limits use in many parts of the world. An antiviral drug—Ribavirin—is licensed for use, but its efficacy is limited.[14]

Scientists are attempting to develop a recombinant Human respiratory syncytial virus vaccine that is suitable for intranasal instillation. Tests for determining the safety and level of resistance that can be achieved by the vaccine are being conducted in the chimpanzee, which is the only known animal that develops a respiratory illness similar to humans.
Vaccine News Daily article "NOVAVAX reports positive RSV vaccine Phase II clinical trial results" published Apr 2, 2013

Laboratory diagnosis

RSV infection can be confirmed using Direct Fluorescent Antibody detection (DFA), Chromatographic rapid antigen detection or detection of viral RNA using RT PCR [Reverse-transcription_polymerase_chain_reaction). Quantification of viral load can be determined by Plaque Assay, antigen capture enzyme immunoassay (EIA), ELISA and HA, and quantification of antibody levels by HAI and Neutralisation assay.

Treatment

Studies of nebulized hypertonic saline have shown that the "use of nebulized 3% HS is a safe, inexpensive, and effective treatment for infants hospitalized with moderately severe viral bronchiolitis" where "respiratory syncytial virus (RSV) accounts for the majority of viral bronchiolitis cases".[15][16]One study noted a 26% reduction in length of stay: 2.6 ± 1.9 days, compared with 3.5 ± 2.9 days in the normal-saline treated group (p=0.05).[15]

Supportive care includes fluids and oxygen until the illness runs its course. Salbutamol may be used in an attempt to relieve any bronchospasm if present. Increased airflow, humidified and delivered via nasal cannula, may be supplied in order to reduce the effort required for respiration. Adrenaline, bronchodilators, steroids, antibiotics, and ribavirin confer "no real benefit".[17][18]
Zoonotic potential

The RSV is virtually the same as chimpanzee coryza virus and can be transmitted from monkeys to humans, although transmission from humans to monkeys is more common.[19] The inactivated polio vaccine was reportedly contaminated with simian viruses, including Chimpanzee coryza, during 1955-1963.[20][21]

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Special Update NVAX – RSV Vaccine Dose Confirmatory Trial Highly Successful

After the close, Novavax announced positive top-line safety and immunogenicity data from its RSV-F protein nanoparticle vaccine candidate in a Phase 2 clinical trial in 720 women of childbearing age. The randomized, blinded, placebo-controlled Phase 2 study was designed to evaluate the immunogenicity and safety of multiple formulations of Novavax' RSV-F protein nanoparticle vaccine adjuvanted with aluminum phosphate. The primary outcome of the trial was safety and immune response, measured by levels of serum IgG antibody specific for the F protein. Participants received either one or two intramuscular injections featuring two different dose levels of vaccine antigen with a range of doses of aluminum phosphate adjuvant. These top-line data over the 91-day period following first immunization were highly successful for safety and efficacy and support Novavax' maternal immunization strategy. With four positive studies in more than 1,100 safety subjects, the current trial represents a major step forward and another de-risking event.

NVAX – RSV Vaccine Dose Confirmatory Trial Highly Successful – After the close, Novavax announced positive top-line safety and immunogenicity data from its RSV-F protein nanoparticle vaccine candidate in a Phase 2 clinical trial in 720 women of childbearing age. The randomized, blinded, placebo-controlled Phase 2 study was designed to evaluate the immunogenicity and safety of multiple formulations of Novavax’ RSV-F protein nanoparticle vaccine adjuvanted with aluminum phosphate. The primary outcome of the trial was safety and immune response, measured by levels of serum IgG antibody specific for the F protein. Participants received either one or two intramuscular injections featuring two different dose levels of vaccine antigen with a range of doses of aluminum phosphate adjuvant. These top-line data over the 91-day period following first immunization were highly successful for safety and efficacy and support Novavax’ maternal immunization strategy. With four positive studies in more than 1,100 safety subjects, the current trial represents a major step forward and another de-risking event. Reiterate our BUY under 6 and 13 TARGET PRICE.

Highlights of the interim results include the following:

The RSV-F vaccine candidate was well tolerated, with no vaccine-related serious adverse events, at all doses and formulations. The safety profile was consistent with data from prior Phase 1 and 2 studies.
Significant increases in RSV-F antibody levels were observed across all doses and formulations, consistent with prior studies. Peak RSV-F antibody levels were observed in the group that received a single dose of vaccine containing 120 µg of antigen with one-third of the aluminum phosphate dose used in prior studies.
Clear increases in RSV neutralizing antibodies were also shown across all doses and formulations, and were strongest in women entering the study with the lowest baseline levels, in confirmation of prior studies.
Vaccine-induced palivizumab-like antibody levels demonstrated strong concordance with anti-RSV-F antibody responses. A single 120 µg antigen dose generated peak palivizumab-like antibody levels of approximately 400 µg/mL, the highest levels seen in any study.
Kinetic analysis of the antibody responses showed rapid increases in antibody levels in all vaccine formulations and dosing regimens. A single 120µg antigen dose generated peak RSV-F and palivizumab-like antibody levels within 14 days of immunization, and high levels of both were sustained through the 91-day observation period.
In our view, the consistency across doses/formulations and compared with previous studies is impressive. The NVAX F-protein vaccine delivered improved immunogenicity in a one-dose regimen, likely leading to improved patient convenience, vaccine uptake and compliance, thus decreasing the burden of RSV disease. In addition the single dose should lead to flexibility for administration during pregnancy. The study confirms a previous clinical trial in women of childbearing age from 2013. These data support the first maternal immunization trial, currently projected to begin in Q4:14.

The Company has requested a Type C meeting with the FDA this summer to discuss the entire suite of pre-clinical and clinical data in support of the initiation of studies in pregnant women. A Type C meeting will allow the company to decide on multiple aspects of the next clinical trial(s). Now they appear to have the appropriate dose/formulation for registration trials – it will be interesting to note if the FDA allows a randomized trial designed for Phase II, but possibly with a crossover to a Phase III study. The impressive results reported today, in our view, makes us believe the path to market could be accelerated. Novavax expects to present the entire date-set at an appropriate scientific forum in the future.

While the most important trials are still ahead of them (e.g., in pregnant women to observe placental transfer of protection, combination trials with the NVAX quadrivalent flu vaccine), today’s results could not be any better. The path to NVAX developing a truly disruptive “respiratory vaccine” has just taken a major step forward.

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Novavax Update (4-28-14)

NVAX – RSV Vaccine Dose Confirmatory Trial Highly Successful – After the close, Novavax announced positive top-line safety and immunogenicity data from its RSV-F protein nanoparticle vaccine candidate in a Phase 2 clinical trial in 720 women of childbearing age. The randomized, blinded, placebo-controlled Phase 2 study was designed to evaluate the immunogenicity and safety [...]

Novavax Update (1-9-14)

Novavax (NVAX) – Stocks of biotechnology companies that reach major inflection points tend to outperform for several years. After a major leap forward in 2013, NVAX is executing its clinical plan with a clearly defined and risk-adjusted strategy. NVAX’s addressable markets are approximately $4 billion per year. Global flu vaccines represent a $3 billion market [...]

Novavax Update (11-14-13)

Special Update – NVAX – Novavax H7N9 Published In The NEJM – First Industry Vaccine For H7N9 Elicits Major Protective Immune Response In Blinding Speed – In a prestigious surprise, Novavax released its Phase I trial of 284 subjects injected with the H7N9 flu virus vaccine – published in the most recent online edition of [...]

Novavax Update (7-31-13)

NVAX – ISCONOVA DEAL SOUND STRATEGIC MOVE – BUY NVAX AHEAD OF CLOSING – BUY UNDER 3 1/2, TARGET PRICE 8. Novavax announced today that as of yesterday (the initial Offer deadline), approximately 97.4% of the common stock and 100% of the warrants issued by Isconova (ISO, , respectively, have been tendered. As a result, [...]

Novavax Update (7-5-13)

NVAX – Novavax Announces Positive Results of RSV F Protein Vaccine in Elderly – Paving Way For The Ultimate INFLUENZA/RSV Combination Vaccine – Raising BUY LIMIT and TARGET PRICE – The successful trial exhibited evidence of a real vaccine across the board. In 220 patients, the F-Protein vaccine: a) was well-tolerated without any vaccine-related serious [...]

Novavax Update (4-25-13)

NovaVax – Why VLPs are VIPs. The key to the NVAX vaccine platform technology is the use of virus-like particles (VLPs) to safely deliver key immune-identifying proteins to the body. Importantly, proof of concept is in place as VLPs are recombinant particles similar to currently marketed vaccines. Merck’s Recombivax HB and GSK’s Engerix B are recombinant [...]

Novavax Update (4-2-13)
BioInvest News, Company 

NovaVax released positive Phase II data from their respiratory syncytial virus (RSV) vaccine development candidate, RSV-F. RSV-F exhibited a robust antibody response and clean safety profile in the trial that enrolled 330 women of childbearing age. The trial is a major step towards the commercial viability of the very first RSV vaccine candidate ever for use [...]

Novavax Update (1-25-13)

NVAX has cleared an important hurdle tied to the government funding for their seasonal and pandemic flu vaccine program. The U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) has completed an In-Process Review of the company’s contract. Subsequently, BARDA has notified NVAX that a milestone decision has been made to [...]

Novavax Update (11-02-12)

NovaVax announced that it has raised a total of $27 million through the sale of 12,285,321 shares of its common stock to RA Capital Management, Camber Capital Management and Ayer Capital Management at a price of $2.18 per share. The shares were offered under an effective shelf registration statement previously filed with the Securities and [...]

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One Year Follow up from RSV F-Protein Vaccine Candidate Phase 1 Elderly  

Trial Demonstrates Sustained Levels of Immune Response  

• Sustained levels of RSV F antibody and palivizumab-competing antibody responses
demonstrated over a 4 to 6 month period
• Results support accelerating development plans for “seasonal” elderly RSV vaccine
• Phase 2 clinical trial in elderly anticipated to start in late-2014/early-2015
Gaithersburg, MD (May 12, 2014) – Novavax, Inc. (NASDAQ: NVAX) today announced
follow-up data from its dose-ranging Phase 1 clinical trial of its respiratory syncytial virus (RSV)
F-protein vaccine in 220 elderly adults (60 years of age and older, with a mean age of 68) that
was initiated in October 2012. In the placebo-controlled trial, subjects received a single injection
of either 60µg or 90µg of the RSV F-protein vaccine candidate, with or without aluminum
phosphate as an adjuvant.

Positive top-line interim safety and immunogenicity data released by Novavax in July 2013
described antibody responses 28 and 56 days post-immunization. Overall immune responses
were greater in groups receiving the 90μg dose compared to the groups dosed with 60µg. Also,
robust anti-F IgG responses and palivizumab competing antibody (PCA) responses were
observed in all vaccine recipients. Notably, by day 56, subjects receiving the 90μg dose without
adjuvant achieved PCA responses at a geometric mean of 142μg/ml, which approximate the peak
levels seen in pharmacokinetics trials of palivizumab in infants receiving repeat palivizumab
injections (~150µg/ml) and exceeded trough levels seen (~70µg/ml) in those same studies,
indicating that the vaccine induced antibody levels that are likely to be protective.

In the one-year follow up data released by Novavax today, the company reported that the group
receiving the 90μg dose without adjuvant, anti-F levels and PCA were significantly elevated over
baseline at day 118, with a geometric mean of 130μg/ml, and at day 180, with a geometric mean
of 114μg/ml. For the same group, at day 180, anti RSV A neutralizing antibodies were log2 8.8
and RSV B neutralizing antibodies were log2 9.0, both considered protective levels in
seroepidemiology studies.

“Typically, RSV season lasts four to five months, so it was important to see follow-up data
which support that our vaccine could be protective across a full RSV season, similar to seasonal
influenza vaccination. Our data suggest that, since protective levels are diminished at day 365,
annual boosts of our vaccine may be warranted,” said Dr. Gregory Glenn, Senior Vice President
of Research and Development at Novavax. “The monoclonal antibody palivizumab has been
shown to protect infants against severe RSV disease but has only a 21-day half-life and is
therefore given in multiple injections to sustain protective levels. A single dose of our RSV F
vaccine candidate appears to sustain immunity in the elderly at levels that exceed what was
protective in infants, and does so over a long-enough period of time to cover an entire RSV
season.”

Stan Erck, President and CEO of Novavax, stated, “We were pleased to see that a 90μg dose of
our RSV F vaccine candidate was immunogenic and sustained levels that appear to be protective
over an entire RSV season. These results encourage us to accelerate our development plans to
include an annual seasonal RSV vaccine for the elderly where there is a burden of disease and
incidence rate similar to that of an influenza virus, and clearly support initiation of a Phase 2
clinical trial as early as later this year or early-2015.

About RSV
RSV is a major respiratory pathogen in infants, children, and adults. RSV infections in adults
represent re-infections and are generally mild to moderate in severity, except in persons with
high-risk conditions including the elderly and adults with underlying chronic cardiac or
pulmonary disease. It is estimated that between 11-17,000 adults die of RSV infection annually
in the U.S., with and up to 180,000 admitted to hospital with respiratory symptoms. Currently,
there is no approved RSV prophylactic vaccine available. Palivizumab is a monoclonal antibody,
licensed and sold by Medimmune as Synagis®, that targets the RSV F protein and is used for
prophylaxis against RSV disease in high risk infants.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel
vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using
innovative proprietary recombinant protein nanoparticle vaccine technology, the company
produces vaccine candidates to efficiently and effectively respond to both known and newly
emergent diseases.

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Novavax CEO: Avian Flu Results Very Positive for Vaccine Maker


VIDEO:  www.thestreet.com/_yahoo/video/12889698/novavax-ceo-avian-flu-results-very-positive-for-vaccine-maker.html?cm_ven=YAHOOV&cm_cat=FREE&cm_ite=NA&s=1


Novavax's recent positive avian flu results demonstrate the company can make vaccines quickly and for a wide range of viruses including Ebola, said the company's CEO Stanley Erck. Erck added that the results show Novavax is on the pathway to a licensed product that will be able to combat future pandemic breakouts. He also said that the company has expanded its deal with the Department of Health and Human Services which will enable it to build infrastructure to develop vaccines. Finally, Erck said the company has over $200 million on its balance sheet to spend on clinical trials of its RSV Vaccine for healthy women in the third trimester of pregnancy.

Stock quotes in this video: NVAX

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Novavax and Collaborators Make Multiple Presentations at the  

9th International Respiratory Syncytial Virus Symposium  

in South Africa, November 9-13, 2014 

Gaithersburg, MD (November 7, 2014) - Novavax, Inc. (Nasdaq: NVAX), a clinical-stage
biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, announced today that representatives of Novavax, along with a number of its research collaborators, will be making multiple oral
presentations and poster presentations related to Novavax’ RSV F-protein nanoparticle vaccine candidate (RSV F Vaccine) at the 9th International Respiratory Syncytial Virus Symposium to be held November 9 – 13, 2014 in Stellenbosch, South Africa.

Poster, presentation titles, and presenters are listed below:
• “Maternal Immunization of Pregnant Baboons with the RSV F Nanoparticle Vaccine
Leads to Transplacental Transfer of High Affinity Functional Antibodies in Infants.”
Robert C. Welliver, M.D., Professor of Pediatrics and Section Chief, The University of
Oklahoma Health Sciences Center
• “Placental Transfer of Anti-RSV F Maternal Antibody in Rabbits and Guinea Pigs
Immunized with an RSV F Nanoparticle Vaccine Co-administered with Aluminum
Phosphate.”
Hanxin Lu, Ph.D., Senior Scientist, Novavax, Inc.
• “A Phase II Randomized, Observer-blind, Placebo-controlled, Dose-ranging Study to
Evaluate the Immunogenicity and Safety of Multiple Formulations of an RSV F
Nanoparticle Vaccine with Aluminum, in Healthy Women of Child-bearing Age.”
Nigel Thomas, Ph.D., Vice President, Clinical Operations, Novavax, Inc.
• “Immunogenicity of the RSV F Nanoparticle Vaccine and Induction of Palivizumab
Competing Antibodies: Review of Immunogenicity Data and Consideration of the
Clinical Relevance.”
Gregory Glenn, M.D., Senior Vice President, Research and Development, Novavax, Inc.
• “Cotton Rats Vaccinated with RSV F-Protein Nanoparticle Vaccine are Protected from

Infection with RSV Wild Type and Palivizumab Escape Mutant Virus.”
Pedro Piedra, M.D., Professor of Molecular Virology and Microbiology, Baylor College
of Medicine About RSV is a widespread disease that causes infections of the lower respiratory tract. While RSV affects individuals of all ages, it acutely impacts infants, the elderly, young children and others with compromised immune systems. RSV is the number one cause of hospitalization in infants ages 0 to 12 months in the U.S. and is a significant cause of infant morbidity and mortality globally. Current estimates indicate that RSV is responsible for over 30 million new acute lower respiratory infection episodes and between 150,000 and 200,000 deaths in children under five years old. In the U.S., nearly all children become infected with RSV before they are two years old; it has been associated with 20% of hospitalizations and 15% of office visits for acute respiratory infection in young children. The World Health Organization (WHO) estimates that the global disease burden for RSV is 64 million cases. Because there is no approved prophylactic vaccine, an RSV vaccine has the potential to protect millions of patients from this far-reaching unmet medical need.

About Novavax
Novavax, Inc. (NASDAQ: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company’s website, novavax.com


www.timeanddate.com/worldclock/south-africa/stellenbosch

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RSV when completed will be the JEWEL IN NOVAVAX'S CROWN!

RSV 

Estimated Enrollment: 150
Study Start Date: November 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

With the historical background of formalin inactivated RSV vaccine, the FDA may throttle the enrollment pace. So it all depends on the data submitted to the FDA from their previous trials, and how comfortable is the FDA with Novavax's RSV-F. Since there are babies involved, I would not be surprised if FDA plays it more conservative and enrollment would take longer. Additionally, a lot of people will not enroll in a clinical trial where it involves their baby, so the pool of patients is that much smaller. Another difficulty is the mothers have to be in their 3rd trimester, so the patient pool gets even smaller. All of the above add up, so do not expect to finish enrollment in 2 weeks like influenza trials. The trial will be enrolled, and in the meantime Novavax has plenty of other trials results to track throughout 2015.

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NOVAVAX: CLINICAL-STAGE PIPELINE

www.novavax.com/go.cfm?do=Page.View&pid=13

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NOVAVAX

VACCINES FOR EMERGING THREATS 

Ebola 

Ebola virus (EV), formerly known as Ebola hemorrhagic fever, is a severe, often fatal illness in humans. Five strains of EV have been identified, the most recent of which, the 2014 Makona-based EV strain, is associated with a case fatality rate of between 50% and 90%. There are currently no licensed treatments proven to neutralize the virus. While a range of blood, immunological and drug therapies are under development, current vaccine approaches target either a previous strain of the virus or were initially developed to target DNA viruses. Our EV glycoprotein (GP) vaccine candidate, which was modeled using the current 2014 Makona-based EV strain, has been successfully tested in rodent, rabbit, and non-human primate pre-clinical models. We have also tested the vaccine with our Matrix-M adjuvant, which appears to significantly contribute to enhanced immunogenicity and dose-sparing.

Middle East Respiratory Syndrome (MERS) 

Middle East Respiratory Syndrome (MERS), is caused by a novel coronavirus first identified in September 2012 by an Egyptian virologist. MERS became an emerging threat in 2013, with the WHO currently reporting more than 850 confirmed cases of infection and more than 350 deaths. The MERS virus is a part of the coronavirus family that includes the severe acute respiratory syndrome coronavirus (SARS). Because of the public health priority given to MERS, within weeks of getting the virus’ sequence, we successfully produced a vaccine candidate designed to provide protection against MERS. This vaccine candidate, which was made using our recombinant nanoparticle vaccine technology, is based on the major surface spike protein, which we had earlier identified as the antigen of choice in our work with a SARS vaccine candidate. In April 2014, in collaboration with the University of Maryland, School of Medicine, we published results that showed our investigational vaccine candidates against both MERS and SARS blocked infection in laboratory studies. Although the development of a MERS vaccine candidate currently remains a pre-clinical program, we believe that our MERS vaccine candidate offers a viable option to interested global public health authorities.

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NOVAVAX ANNOUNCES MANAGEMENT PROMOTION 

GAITHERSBURG, Md., June 15, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that Chris Dunne has been named Vice President, Finance. Mr. Dunne joined Novavax as the Executive Director, Finance in January 2010, with responsibility for financial reporting. Prior to joining Novavax, he was Senior Director, Finance at Ore Pharmaceuticals (previously known as Gene Logic), a publicly traded biotechnology company, from 1996 until joining Novavax in 2010.

Mr. Dunne’s prior experience includes roles as a Senior Project Accountant for Akridge, where he was responsible for the accounting activities of a portfolio of commercial real estate partnerships and corporations located in the Washington, D.C., metropolitan area and with Deloitte & Touche LLP, where he managed audits for a number of public and private companies, including preparation for initial public offerings and SEC reporting. Mr. Dunne received a B.S. degree in Business Management, Accounting from the University of Maryland and is a Certified Public Accountant.

“Chris was an instrumental part of the team that secured our $179 million contract with HHS-BARDA and his leadership in finance and accounting has been central to our growth as a company,” said Stanley C. Erck, President and CEO. “Chris’ expertise will continue to be important as we advance our programs to late-stage clinical trials and ultimately seek to bring our RSV F Vaccine to market.”