
H5N1
SAN DIEGO — Vical Inc. announced Feb. 24 the publication in the online edition of Vaccine1 detailed data from two Phase 1 trials of its Vaxfectin-adjuvanted DNA vaccines for H5N1 (avian-origin) influenza.
"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," said Larry Smith, Vical’s vice president of vaccine research and the lead author on the paper.
The double-blind, placebo-controlled, dose-escalation H5N1 Phase 1 trials were conducted in approximately 100 healthy volunteers ages 18 to 45 at three U.S. 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.
No significant safety issues were observed at any of the vaccine doses tested, clearing the path for additional human trials of Vaxfectin-adjuvanted vaccines, the company said in a press release.
