Vical Announces Breakthrough for Pandemic Influenza DNA Vaccines With Preliminary ...(vaccine will help address the potential ...),Health

Vijay B. Samant, Vical's President and Chief Executive Officer, said, "Our preliminary Phase 1 pandemic influenza vaccine results clearly demonstrate the potential of Vaxfectin(R)-formulated DNA vaccines to achieve antibody responses in the same range as conventional vaccines. The ability to manufacture DNA vaccines in weeks rather than the months required for conventional vaccines may provide a significant advantage when dealing with an emerging infectious disease such as pandemic influenza. This trial is also important because it marks the first successful safety evaluation in humans for our Vaxfectin(R) adjuvant, which has potential applications with both DNA vaccines and conventional protein-based vaccines."

The double-blind, placebo-controlled, dose-escalation trial was conducted in approximately 100 healthy volunteers age 18 to 45 at three U.S. clinical sites. The trial was designed to assess safety and immunogenicity following intramuscular vaccination with needle and syringe or with the Biojector(R) 2000 needle-free injection system in different cohorts, and to evaluate monovalent and trivalent Vaxfectin(R)-formulated DNA vaccines at various doses. Preliminary results will be presented by Vical's Vice President of Vaccine Research, Larry R. Smith, Ph.D., at 12:25 p.m. EDT today, Thursday, July 17, at the IBC Life Sciences Next Generation Vaccines conference (National Harbor, MD - July 17-18).

In the Phase 1 trial, subjects were injected at Days 0 and 21. Primary evaluation of antibody responses was by HI antibody titers, the accepted standard correlate of protection for influenza vaccines. Responders were those subjects achieving H5 HI titers of at least 40 and achieving at least a four-fold increase from baseline HI titers. By Day 56, at least 50% and up to 67% of evaluable subjects were responders in each of the three cohorts receiving 0.5 mg or 1 mg
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