Challenge
The high-profile Zika virus outbreak in 2016 proved that the disease causes serious birth defects in humans and highlighted an immediate need for an approved vaccine. Based on our successful track record in vaccine testing, Battelle was chosen to evaluate the systemic toxicity, local tolerability and immunogenicity of a Biopharma company’s purified recombinant protein vaccine candidate. The vaccine was under a clinical hold order from the FDA, which prevented it from going to clinical study in humans.
Solution
Battelle performed GLP toxicology and immunogenicity testing and demonstrated that the vaccine generated a systemic immune response without systemic or local toxicity in preclinical models.
Impact
The FDA accepted Battelle's data, removed the clinical hold and allowed progression of the vaccine candidate to clinical trials. The vaccine candidate was granted fast-track designation by the FDA.