Novavax Announces Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program
Novavax, Inc. announced favorable results from the second stage of the Phase I/IIa human clinical trial of its pandemic influenza virus-like particle (VLP) vaccine candidate. The vaccine, which does not contain an adjuvant, induced robust neutralizing antibody responses. Novavax's 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), 45 mcg, 90 mcg or placebo. Among those individuals in the 15 mcg arm, 72% had a neutralizing antibody titer of 1:20 or greater (four-fold rise from baseline) against the H5N1 A/Indonesiastrain as did 73% of subjects in the 45 mcg arm and 94% of subjects in the 90 mcg arm. All subjects tested negative for neutralizing antibodies to the H5N1 A/Indonesiastrain before vaccination and no responses were observed among individuals who received a placebo. Novavax's proprietary VLPs contain the surface proteins (hemagglutinin [HA] and neuraminidase [NA]) and matrix protein (M1) of the H5N1 A/Indonesiastrain. Additional immunological responses induced by each of the components of the vaccine are being evaluated including responses against HA, NA and the M1 proteins.
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 90 mcg dose.
"These data are exciting because they demonstrate that recombinant VLPs are a valid and potent vaccine approach against influenza. Combined with our innovative manufacturing approach, our VLP vaccine candidate has the potential to address an unmet need in pandemic influenza preparedness efforts being planned by health authorities around the world," said Dr.Rahul Singhvi, President and CEO of Novavax.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
