CLINICAL TRIALS AND PIPELINE

[dothedd]

CLINICAL TRIALS 

Novavax NCT02078674: A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant

Novavax NCT01960686: RSV F Dose-Ranging Study in Women

Novavax NCT01897701: A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1

Novavax NCT01709019: A Phase I Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum Adjuvant, and Co-administered With a Licensed Inactivated Influenza Vaccine, in Healthy Subjects ≥ 60 Years of Age

Novavax NCT01704365: A Phase II Randomized, Observer-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum, in Healthy Women of Child-Bearing Age

Novavax NCT01596725: A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 2

Novavax NCT01594320: A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 1

Novavax NCT01561768: A Phase 2 Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Quadrivalent Seasonal Virus-Like Particle (VLP) Influenza Vaccine (Recombinant) in Healthy Young (18-64) Adults

Novavax NCT01290419: A Phase I, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 4 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age)

Novavax NCT01014806: Phase IIa trial to evaluate the safety and immunogenicity of a trivalent seasonal influenza virus-like-particle (VLP) vaccine (recombinant) in older adults

Novavax NCT01072799: Phase II trial to assess the safety and immunogenicity of an A (H1N1) 2009 Influenza virus-like particle (VLP) Vaccine

Novavax NCT00903552: Phase IIa randomized, double blind, placebo controlled trial to evaluate the safety and immunogenicity of a trivalent seasonal influenza virus-like particle (VLP) vaccine (recombinant) in healthy adults

Novavax NCT00754455: A Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults

Novavax NCT00519389: Phase I/IIa Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an H5N1 Virus-Like Particle (VLP) Influenza Vaccine (Recombinant)


Clinical trials are an essential step in the process of validating the vaccine candidates put forth by our company. Novavax is currently conducting clinical trials for influenza and RSV vaccines, and by virtue of these trials, we hope that our vaccines against both viruses will one day play a role in the reduction of the spread of these dangerous infectious diseases.

[dothedd]

Influenza Vaccines

Novavax is in advanced development of VLP vaccines against both seasonal and pandemic influenza. Novavax produced VLP vaccine against the 2009 H1N1 pandemic “swine flu” influenza. In a clinical trial of more than 4,000 subjects in Mexico – where the pandemic was first recognized, the H1N1 VLP vaccine was well tolerated and immunogenic even at the lowest dose tested of five micrograms and after one immunization.

Transmission of the highly pathogenic avian H5N1 flu virus “bird flu” in domestic poultry and humans is continuing in many countries worldwide and remains a serious pandemic threat with the potential to evolve into new strains where cross-protection and induction of neutralizing antibodies will be essential. Novavax has shown in a human studies that its H5N1 VLP vaccine was well tolerated, produced no vaccine-related serious adverse events and induced neutralizing antibodies that were cross-reactive with different avian H5N1 influenza viruses. This is the only report of an unadjuvanted vaccine inducing cross-reactive neutralizing antibodies against multiple clades of H5N1 influenza virus and demonstrates the significant potential of the VLP technology. Novavax is currently pursuing the advanced development of recombinant pandemic and seasonal influenza vaccines, under a contract with the U.S. Department of Health and Human Services’ Office of Biomedical Advanced Research and Development Authority.

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

[billisonboard]

I hate it when a pipeline blocks my trail to the clinic.  

[dothedd]

May 12, 2014 8:49:58 GMT -5 billisonboard said:

I hate it when a pipeline blocks my trail to the clinic.  

Nice dog ...  what's its name?

[Deleted]

May 12, 2014 8:49:58 GMT -5 billisonboard said:

I hate it when a pipeline blocks my trail to the clinic.  

Or worse yet, right through your pot field.

[billisonboard]

May 12, 2014 16:29:45 GMT -5 dothedd said:

May 12, 2014 8:49:58 GMT -5 billisonboard said:

I hate it when a pipeline blocks my trail to the clinic.  

Nice dog ...  what's its name?

Calvin. He was the greatest hiking partner. Lost him a couple of years ago.

[dothedd]

May 12, 2014 18:24:07 GMT -5 billisonboard said:

May 12, 2014 16:29:45 GMT -5 dothedd said:

Nice dog ...  what's its name?

Calvin. He was the greatest hiking partner. Lost him a couple of years ago.

Bill, so sorry about the loss of your hiking partner ... I truly know the heartache you feel. 

My Baby Dog, Honey, went to Heaven April 22, 2013 and I miss her every day.  I am still finding milk bones that she hid all over the house, and when I find one I feel the loss of her all over again. Friends ask me why not replace her, and I say that Honey is not replaceable. 

[dothedd]

May 12, 2014 17:32:09 GMT -5 @joey said:

May 12, 2014 8:49:58 GMT -5 billisonboard said:

I hate it when a pipeline blocks my trail to the clinic.  

Or worse yet, right through your pot field.

That too!! 

[billisonboard]

Sorry, didn't mean to hijack the thread. 

[dothedd]

May 12, 2014 18:58:50 GMT -5 billisonboard said:

Sorry, didn't mean to hijack the thread. 

Not to worry Bill ... sometimes I feel alone in a world of gloom and doom and interfacing with humans  -- is a welcome change in lieu of   ...   

Have a good evening!

[dothedd]

CLINICAL TRAILS JOURNAL

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