Vaccine Publishes Vical’s H5N1 Results

The double-blind, placebo-controlled, dose-escalation H5N1 Phase 1 trials were conducted in approximately 100 healthy volunteers age 18 to 45 at three US clinical sites. The trials were designed to assess safety and immunogenicity following vaccination, and to evaluate monovalent and trivalent Vaxfectin-formulated H5N1 pandemic influenza DNA vaccines at various doses.

The vaccines were 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.

Larry Smith, vice president of vaccine research at Vical and the lead author on the paper, said: “Our Phase 1 results clearly demonstrated the ability of DNA vaccines against H5N1 avian-origin influenza to achieve antibody responses in the same range as conventional vaccines. These trials are key to expanding the use of our Vaxfectin adjuvant as they provided its first successful safety evaluations in humans. We seized the opportunity to further demonstrate the potential of our technology during the 2009 H1N1 pandemic influenza outbreaks.

“We completed successful pilot lot production and initiated animal immunogenicity testing of a Vaxfectin-adjuvanted DNA vaccine for H1N1 pandemic influenza before conventional vaccine manufacturers even received the seed virus needed to start production. We published these data in late 2009, and expect to begin a US government-funded Phase 1 clinical trial of our H1 pandemic influenza vaccine soon.”