Enterotoxigenic Escherichia Coli Manufactured Product

The primary objective of this sources sought notice is delivery of a cGMP manufactured product of quantity and quality that it is suitable and appropriate for use in pivotal clinical studies to demonstrate efficacy against Enterotoxigenic Escherichia coli (ETEC) in adults with the goal of FDA licensure. The objective activities will support a multivalent ETEC vaccine with the long-term goal of preventing bacterial diarrhea in Warfighters.

Potential offerors must include the preparation of a Controlled Human Infection Model (CHIM) Phase 3 Clinical study and conversion of FDA required documentation into the FDA required format. Potential offerors will use a European Contract Manufacturing Organization (CMO) to meet FDA quality requirements.