# Enterotoxigenic Escherichia Coli Manufactured Product

Canonical: https://abierto.us/opportunities/ht942524ssntjk1

- Solicitation number: HT9425-24-SSN-TJK1
- Notice type: Sources sought
- Status: Closed. Deadline was August 13, 2024 at 12:00 AM EDT
- Department: Department of Defense
- Agency: Defense Health Agency (Dha)
- Contracting office: Army Med Res Acq Activity (HT9425)
- NAICS: 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Product or service code: Q517 Pharmacy Services
- Place of performance: Frederick, North Dakota
- First posted: August 7, 2024
- Last posted: August 7, 2024
- SAM.gov: https://sam.gov/workspace/contract/opp/4d442b9c0ad44ba18bf5b6a374ac4589/view

## Description

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.

## Publications

- August 7, 2024: Sources sought, due August 13, 2024 at 12:00 AM EDT. Notice 4d442b9c0ad44ba18bf5b6a374ac4589. https://sam.gov/workspace/contract/opp/4d442b9c0ad44ba18bf5b6a374ac4589/view

## Points of contact

- Timothy Kelly, timothy.j.kelly169.civ@health.mil, 3016197806

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/ht942524ssntjk1.