Novavax has reported positive results from the first stage of a two-stage pivotal Phase II study evaluating the safety and immunogenicity of the 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 the study, 1,000 healthy volunteers aged 18 to 64 years old were enrolled to receive two doses of 5mcg, 15mcg or 45mcg of Novavax’s 2009 H1N1 influenza VLP or a placebo to determine the safety and immunogenicity of the vaccine.
Independent Data and Safety Monitoring Board (DSMB) finds that a single dose of 15mcg or 45mcg of H1N1 VLP is well tolerated and produces a robust immune response. 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.
In this subset of 500 subjects from stage A, the hemagglutinin inhibition (HAI) antibody titers 14 days post dose one in the 15 and 45mcg arms met the seroconversion and seroprotection criteria recommended by the US and European regulatory authorities.
The company said that 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 15mcg single dose regimen. The safety and immunogenicity data from all 1,000 subjects in stage A will be available in January, 2010.
Rahul Singhvi, president and chief executive officer of Novavax, said: “It is a 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 commercialisation of this vaccine in Mexico and potentially other countries.”