This clinical trial focused on the immunogenicity of a three-dose BioThrax (Anthrax Vaccine Adsorbed) regimen when used for post-exposure prophylaxis (PEP) in adults. The primary objective of the clinical trial was to determine the timing and peak of the immune response following three doses of BioThrax for PEP. This study, together with non-clinical and clinical studies planned during 2008, is intended to support a proposed application to the Food and Drug Administration to expand the approved indication for BioThrax to include PEP.
Fuad El-Hibri, chairman and CEO of Emergent, said: “We are very pleased to have reached this contract milestone in our pursuit of achieving a PEP indication for BioThrax. We recognize how significant the development of a post-exposure prophylaxis indication is to fulfilling our mission to protect life. Department of Health and Human Services (HHS) shares our commitment to this important project and we are grateful for their support as we continue to make progress on this critical program.”