Manufacturing of an Enterotoxigenic Escherichia coli (ETEC) Vaccine for the Treatment of Bacterial Diarrhea for Use in Pivotal Clinical Trials
Closed Pre-Solicitation Posted
- Solicitation number
- HT9425-24-RFI-TJK-01
- Agency
-
Defense Health Agency
Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- PSC
- Q517 Pharmacy Services
- Place of performance
- Frederick, Maryland 21702, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The United States Army Medical Materiel Development Activity is seeking to clinically evaluate and achieve FDA licensure of a multivalent vaccine to induce active immunity against Enterotoxigenic Escherichia coli (ETEC) for the prevention of traveler's diarrhea in the military population aged 18-55. The Defense Health Agency is conducting market research to determine if a commercial solution can meet the requirements for developing an FDA-licensed ETEC vaccine. Key requirements include the vendor owning or licensing the investigational product, having demonstrated manufacturing and quality processes to support a Biologics License Application, and having clinical evidence of the product's potential to prevent ETEC-induced diarrhea in adults. Vendors should provide a white paper, cost estimate, and contact information by the August 28, 2024 response deadline.
This pre-solicitation notice does not indicate any set-aside designation. The potential contract value or budget range is not specified. The NAICS code is 541714 - Research and Development in Biotechnology, and the PSC code is Q517 - Pharmacy Services. This market research may assist in further development of the requirements for a future solicitation.
Notice text
United States Army Medical Materiel Development Activity seeks to clinically evaluate and achieve U.S. Food and Drug Administration (FDA) licensure of a multivalent vaccine to induce active immunity against ETEC for the prevention of traveler’s diarrhea to protect the Force (population 18-55 years of age). United States Army Medical Research Acquisition Activity is conducting market research to determine whether a commercial solution can be provided to meet requirements for developing a FDA licensed ETECV for the prevention of bacterial-induced diarrhea. This market research may also assist with the further development and/or refinement of the requirements.
Files
| File | Type | Posted |
|---|---|---|
| ETEC RFI Doc.docx | DOCX document |
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