Emergent BioSolutions (NYSE:EBS) has received agreement from the European Medicines Agency (EMA) to pursue the proposed development plan for its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate.
The company has proposed conducting a safety and immunogenicity Phase 3 trial using Serum Neutralizing Antibodies (SNA) as an immune correlate of protection to predict clinical benefit of the vaccine candidate.
Emergent’s CHIKV VLP vaccine candidate is currently being investigated in a Phase 2 parallel-group, dose-finding study of approx. 430 healthy adults at three U.S. sites. It is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
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