Additional Relevant Details The agreement also includes Sanofi Pasteur’s production of clinical material in compliance with current GMP (Good Manufacturing Practices) to support phase II testing, optimization of the upstream process to improve production yields, and characterization of the vaccine product. Sanofi Pasteur will also create a clinical development and regulatory strategy.
WRAIR will share data related to the development of immunologic assays designed to measure neutralizing antibody responses following natural infection and vaccination with ZPIV, biologic samples generated during the performance of non-human primate studies, and biologic samples generated during the performance of human safety and immunogenicity studies using ZPIV. WRAIR, the National Institute of Allergy and Infectious Diseases (NIAID)–part of the U.S. National Institutes of Health (NIH), and theBiomedical Advanced Research and Development Authority (BARDA)–part of the Health & Human Services (HHS) Office of the Assistant Secretary of Preparedness and Response–have been coordinating pre-clinical development of the candidate encouraged by new, pre-clinical research conducted by WRAIR and the Beth Israel Deaconess Medical Center[1]. NIAID will sponsor a series of phase 1 ZPIV trials while the technology transfer process is occurring.