PharmAthene plans phase II anthrax vaccine trial
SparVax is a second generation recombinant vaccine that uses PharmAthene's E. coli-based rPA technology platform. The vaccine has been manufactured to full cGMP standards and the trial will employ the drug product in syringes that have been pre-filled. The new process will give SparVax an improved yield when compared with the first-generation vaccine, Fierce Vaccine reports.
In prior preclinical and clinical trials, SparVax exhibited protection against anthrax that was between 90 and 100 percent when given to subjects in six or 12 month booster doses.
"SparVax has previously been evaluated in two separate Phase II clinical trials involving approximately 770 subjects," Thomas Fuerst, the CSO and executive vice president of PharmAthene, said, according to Fierce Vaccine. "This latest phase II trial, which we expect will commence in the second half of this year, will be a dose-ranging and schedule study designed to evaluate the safety and immunogenicity of SparVax in approximately 300 healthy subjects."
BioThrax, a vaccine developed by Emergent Solutions, is the current anthrax vaccine used in the United State. It is the only FDA approved vaccine for the fight against anthrax.