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AlphaVax Announces Results From Phase 1 Influenza Vaccine Clinical Trial
Date:10/31/2007

RESEARCH TRIANGLE PARK, N.C., Oct. 31 /PRNewswire/ -- AlphaVax, Inc. announced today that it has concluded a phase 1 clinical trial in 216 volunteers of an influenza vaccine based on its proprietary replicon vector platform. This study was designed to further assess the properties of this unique vector system as well as the feasibility of its application to influenza vaccines.

The study was a placebo-controlled, randomized, double-blind trial in healthy adults, 18-40 years old, which evaluated the safety and humoral and cellular immune responses after one or two inoculations. The replicon vector expressed the hemagglutinin (HA) gene derived from the A/Wyoming (H3N2) strain of influenza virus. The vaccine was administered either subcutaneously or intramuscularly at two dosage levels, and was found to be safe and well tolerated irrespective of the route or the dose given.

Both antibody and T cell responses were efficiently stimulated and persisted for the duration of the four-month study. Among volunteers with prevaccination influenza antibody titers (measured by hemagglutination inhibition, or "HI") that were below levels thought to be protective, 77% and 80% of these individuals receiving a single low or high dose, respectively, responded with protective HI antibody titers. A second immunization in these individuals increased seroprotective responses to 86% for both dosage levels. A rapid and dose-dependent T cell response (defined in antigen-specific IFN-gamma ELISPOT assays) was also observed and remained significantly elevated for at least four months. A second immunization extended the duration, but not the magnitude of these T cell responses. For both antibody and cellular responses, there was no significant difference observed between subcutaneous and intramuscular vaccinations.

"We were pleased to see the balanced immune response consisting of both humoral and cellular responses", said Dr. Jonathan Smith, CSO at AlphaVax. "Comparable
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SOURCE AlphaVax, Inc.
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