Research and Development of Multi-Strain PfSPZ Malaria Vaccine

Contract Award Announcement/J&A posting.

SYNOPSIS: The U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division (NCD), on behalf of the Advanced Medical Development (AMD) Program Office of Naval Medical Research Center (NMRC), intends to award a Cost Type contract on a sole source basis to Sanaria, Inc., for the development of a large scale manufacturing process for producing a Multi-Strain PfSPZ malaria vaccine that is in compliance with current Good Manufacturing Practices (cGMPs) and can produce the quantity of malaria vaccine needed to conduct late Phase 2 dose optimization and Phase 3 clinical trials in support of licensure of such a vaccine. The vaccine must utilize aseptic, purified, cryopreserved PfSPZ that are attenuated by radiation, anti-malaria drugs, and/or genetic attenuation. In addition, the vaccine must be administered intravenously. Sanaria, Inc., a small business located in Rockville, MD is the only responsible source for this effort based on Market Research, and Sanaria, Inc. is the only vendor that is developing a malaria vaccine utilizing irradiated aseptic, purified, cryopreserved, attenuated (non-replicating), metabolically active Plasmodium falciparum (Pf) sporozoites (SPZ) extracted from mosquitos that are grown and incubated. As such, this contract will be awarded to Sanaria, Inc. The applicable NAICS code is 541711 with a size standard of 1000 employees. This synopsis expires on September 4, 2017, 3:30PM EST. Please direct any questions to Shawn Haubner at shawn.p.haubner.civ@mail.mil.