Gene-based Zika Vaccine Shows Promise in Phase I Trials

This is the tale of two stories: World Pharma News recently reported that “Results from two Phase 1 clinical trials show an experimental Zika vaccine developed by government scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is safe and induces an immune response in healthy adults. The findings will be published on Dec. 4 in The Lancet. NIAID is currently leading an international effort to evaluate the investigational vaccine in a Phase 2/2b safety and efficacy trial.”

At about the same time, FiercePharma reported “Regret it or not, the Zika vaccine Sanofi walked away from shows early promise… The purified, inactivated Zika vaccine (ZPIV) candidate Sanofi left behind amid mounting political pressure over pricing has shown promise in a trio of phase 1 studies, having elicited robust neutralizing antibody responses in almost all vaccine recipients. Researchers injected 67 early participants from three sites in the U.S. with either two injections of the Zika vaccine or placebo. Among 52 vaccine recipients, 48 (92%) had seroconverted, reaching a geometric mean titer threshold of 1:10, which means that they’ve developed meaningful antibodies. Only mild to moderate adverse events were observed.”

Following are links to the World Pharma News story, the FiercePharma story, and the Lancet article.  Contact us for help with your next FDA submission.