FDAnews
www.fdanews.com/articles/96479-alphavax-announces-interim-results-from-influenza-vaccine-trial

AlphaVax Announces Interim Results From Influenza Vaccine Trial

July 30, 2007

AlphaVax announced results from an interim review of the data from a Phase I clinical trial of an influenza vaccine that is based on its platform replicon vector technology.

The trial is a placebo-controlled, randomized, double-blind, single-center study involving 216 healthy volunteers between the ages of 18 and 40, AlphaVax said.

According to the company, the data are from the analysis of samples taken four weeks after a single dose of the vaccine was administered — at one of two dosage levels. The vaccine has proven to be safe and well-tolerated, the company added.

Among those individuals who had prevaccination influenza serum antibody titers — measured by hemagglutination inhibition (HI) — that were below levels deemed protective against influenza infection, 77 percent of those receiving a low dose of the vaccine and 80 percent of the individuals receiving a higher dose demonstrated protective HI serum antibody titers after a single dose of the influenza vaccine, the company said.