Advancing ZIKA Vaccines

The high-profile Zika virus outbreak in 2016 proved that the disease causes serious birth defects in humans and highlighted a need for vaccines and treatments. Based on our successful track record in assay development and vaccine testing, Battelle was chosen to pursue development of assays to detect the virus in certain nonclinical and clinical samples and to evaluate the immune response induced by Zika virus infection or vaccination, and separately to evaluate the efficacy and immunogenicity of multiple Biopharma companies’ vaccine and therapeutic candidates in nonclinical and clinical studies.

Battelle performed nonclinical studies and clinical sample testing to demonstrate the vaccines generated a systemic immune response and multiple candidate vaccines and therapeutics protected from Zika virus infection in the nonclinical models. Battelle performed further studies to qualify and validate relevant immunogenicity assays according to FDA guidelines, allowing for high confidence in data generated from clinical trials.

The data generated at Battelle in nonclinical studies supported multiple candidate vaccine products moving into clinical trials. The immunogenicity data from clinical sample testing supported one candidate vaccine’s continuance through Phase 1 and into Phase 2.