defence.professionals | defpro.comPosted: March 6, 2012
Vical Incorporated announced Mar. 5 that the Naval Medical Research Center (NMRC) has initiated a Phase 1 human clinical trial of a tetravalent dengue DNA vaccine formulated with the company’s Vaxfectin adjuvant. The trial is based on exciting efficacy data from a nonhuman primate study recently published in the journal Vaccine1. Vical manufactured the vaccine and the adjuvant for both the preclinical and clinical studies, and is providing regulatory and clinical expertise to NMRC for the dengue program.
Vical completed three prior Phase 1 trials, with no safety issues and no dose-limiting toxicity, of Vaxfectin-formulated DNA vaccines against H5N1 and H1N1 pandemic influenza.
Under a prior Collaborative Research and Development Agreement (CRADA) with Vical, NMRC developed a tetravalent DNA vaccine (TVDV) containing genes encoding the pre-membrane (prM) and envelope (E) proteins for all four serotypes of dengue virus, and formulated with Vical’s Vaxfectin adjuvant. Both Vaxfectin-formulated and unformulated vaccines are now being evaluated in Phase 1 human testing. A total of 40 subjects will be assigned to three dose groups: a low dose TVDV without adjuvant, a low dose TVDV with Vaxfectin adjuvant, or a high dose TVDV with Vaxfectin adjuvant. Vaccines will be administered by intramuscular injections on days 0, 30 and 90, with follow-up through approximately one year. Key endpoints in the trial will be safety and immunogenicity.