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news.Novavax has announced favorable results from the second stage of the Phase I/IIa human clinical trial of its pandemic influenza virus-like particle vaccine candidate.
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Novavax said that the vaccine, which does not contain an adjuvant, induced robust neutralizing antibody responses. Novavax’s virus-like particle (VLP) candidate is directed against the H5N1 A/Indonesia/05/2005 avian influenza strain.
In this study, the vaccine demonstrated strong neutralizing antibody titers across all three doses tested, exhibiting increasing antibody titers with the escalation of the dose.
The study evaluated individuals who received two injections of 15 micrograms (mcg), 45mcg, 90mcg or placebo. Among those individuals in the 15mcg arm, 72% had a neutralizing antibody titer of 1:20 or greater (four-fold rise from baseline) against the H5N1 A/Indonesia strain as did 73% of subjects in the 45mcg arm and 94% of subjects in the 90mcg arm.
All subjects tested negative for neutralizing antibodies to the H5N1 A/Indonesia strain before vaccination and no responses were observed among individuals who received a placebo.
Although the safety data are still blinded pending complete safety follow-up, there have been no serious adverse events reported. An independent external data and safety monitoring board fully supported continuation of the study including expansion to the 90mcg dose.
Novavax said that its proprietary VLPs contain the surface proteins (hemagglutinin (HA) and neuraminidase (NA)) and matrix protein (M1) of the H5N1 A/Indonesia strain. Additional immunological responses induced by each of the components of the vaccine are being evaluated including responses against HA, NA and the M1 proteins.