NOVAVAX Reports Positive Clinical Results from Pivotal Study of H1N1 Influenza Vaccine in Mexico
- Category: Vaccines
- Published on Wednesday, 02 December 2009 02:00
- Hits: 1110
- Independent Data and Safety Monitoring Board (DSMB) finds that a single dose of 15 mcg or 45 mcg of H1N1 VLP is well tolerated and produces a robust immune response
- Early data show Novavax's VLP vaccine met the seroconversion and seroprotection criteria recommended by the U.S. and European regulatory authorities
- DSMB recommends 15 mcg single dose vaccine regimen for Stage B (3,000 subjects) of the pivotal study
- Enrollment for Stage B to begin immediately
ROCKVILLE, MD, USA | December 2, 2009 | Novavax, Inc. (Nasdaq: NVAX - News) today reported favorable initial results from the first stage of a two-stage pivotal Phase II study evaluating the safety and immunogenicity of the company's 2009 H1N1 virus-like particle (VLP) pandemic influenza vaccine. Novavax is conducting this study in collaboration with Avimex Laboratories of Mexico to support registration of the vaccine in Mexico and potentially other countries.
In Stage A of this study, 1,000 healthy volunteers aged 18 to 64 years old were enrolled to receive two doses of 5 mcg, 15 mcg or 45 mcg of Novavax's 2009 H1N1 pandemic influenza VLP or a placebo to determine the safety and immunogenicity of the vaccine. The DSMB reviewed preliminary safety and immunogenicity data 14 days post dose one from a subset of approximately 500 subjects enrolled in this stage of the trial. The vaccine was found to be well tolerated at all three dose levels and exhibited no systemic side effects in this review period. Local site reactions were mild. In this subset of 500 subjects from Stage A, the hemagglutinin inhibition (HAI) antibody titers 14 days post dose one in the 15 and 45 mcg arms met the seroconversion and seroprotection criteria recommended by the U.S. and European regulatory authorities. Based on these findings, the DSMB recommended that the study proceed to Stage B of testing in which vaccine safety will be evaluated in 3,000 subjects with a 15 mcg single dose regimen. The safety and immunogenicity data from all 1,000 subjects in Stage A will be available in January, 2010.
Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax, stated: "We believe this is the best possible outcome for our vaccine development program because it suggests that a single 15 mcg dose of our 2009 H1N1 VLP pandemic influenza vaccine will be well tolerated, immunogenic and competitive with currently marketed H1N1 influenza vaccines which are being administered at the same dose. The trial's speedy turnaround from start of enrollment on October 19, 2009 to data review in less than six weeks is a testament to the enormous dedication of the Mexican-U.S. team. It is also clear evidence of what Novavax's technology is capable of providing as a rapid response to a pandemic situation. The DSMB's decision will enable us to begin enrollment in the second stage of this trial immediately and begin final preparations for possible registration and commercialization of this promising vaccine in Mexico and potentially other countries."
Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology. Novavax's VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.
Novavax, Inc. is a clinical-stage biotechnology company, creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com.