Vical Summarizes Successful Phase 1 Trial For Pandemic Flu Vaccine
Larry R. Smith, Ph.D., Vical's vice president of vaccine research, presented the results and outlook at the WHO Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials in Geneva on February 12-13.
The double-blind, placebo-controlled, dose-escalation Phase 1 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 vaccination, and to evaluate monovalent and trivalent Vaxfectin(r)-formulated H5N1 pandemic influenza DNA vaccines at various doses. The vaccines were safe and well-tolerated in the trial, and induced antibody responses and T-cell responses against a matching strain of influenza virus, and cross-clade antibody responses against different strains.
Vical is currently exploring potential sources of funding for further development toward commercialization. The company's near-term goals are to confirm vaccine safety and immunogenicity in a larger number of subjects, optimize vaccine dose and adjuvant ratio, explore prime-boost regimens with different vaccines, and leverage the Phase 1 proof of concept for its DNA vaccine platform and Vaxfectin(r) adjuvant into additional indications.
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