In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|September 2, 2009
Novavax Achieves Good Results for Vaccines Against Seasonal Flu and H1N1
Author(s)Laura Bush
Novavax (Rockville, MD) recently achieved positive Phase 2a results for its trivalent virus-like particle (VLP) vaccine against seasonal influenza, and positive preclinical results for a VLP vaccine against H1NI (swine) flu.
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Novavax (Rockville, MD) recently achieved positive Phase 2a results for its trivalent virus-like particle (VLP) vaccine against seasonal influenza, and positive preclinical results for a VLP vaccine against H1NI (swine) flu.
In the Phase 2 trial for seasonal flu, the VLP vaccine induced strong hemagglutination inhibition (HAI) antibody responses against the influenza H1N1, H3N2, and B strains. Robust HAI responses were also observed against drifted H3N2 strains, showing the potential for VLP vaccines to be cross-protective against flu viruses from different seasons without the addition of an adjuvant. The vaccine was also well tolerated and no serious adverse events were reported.
The preclinical study for H1N1 in ferrets was conducted jointly by Novavax and the Centers for Disease Control and Prevention (Atlanta, GA). All of the H1N1 vaccinated animals, including those in the lowest (3.75 mcg) dose group, developed hemagglutination inhibition (HI) antibody titers of 1:40 or higher, considered a protective level of immunity, against the H1N1 virus.
Novavax produced the candidate H1NI vaccine and delivered it to the CDC in less than four weeks from the day the genetic sequences of the virus strain became available. The speed at which a vaccine can be produced is one of the main advantages of the VLP technology.
Previous coverage:
May 4, 2009
An Alternative to the Scale-up and Distribution of Pandemic Influenza Vaccine
Jan 2, 2009
James M. Robinson
July 9, 2009
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