SAM #RRPV-26-13-BundiVx

BARDA Solicitation for Bundibugyo Virus Vaccine Development Using VSV Platform

This opportunity from BARDA (Biomedical Advanced Research and Development Authority), part of ASPR at HHS, seeks proposals for rapid development and production of Bundibugyo virus (BDBV) vaccines using the VSV vaccine platform. - Government Buyer: - U.S. Department of Health and Human Services (HHS) - Administration for Strategic Preparedness and Response (ASPR) - Biomedical Advanced Research and Development Authority (BARDA) - OEM Technology Highlighted: - VSV (Vesicular Stomatitis Virus) vaccine platform - Products/Services Requested: - Manufacturing process development for BDBV vaccine candidates using the VSV platform - Production of up to 10,000 doses of cGMP Phase 1 clinical trial material (CTM), with options for up to 100,000 doses - IND-enabling nonclinical activities and early regulatory engagement - Phase 1 safety and immunogenicity clinical trial - Unique/Notable Requirements: - Vaccine candidates must leverage the VSV platform, which has proven single-dose protection in Ebola outbreaks - Rapid scale-up and readiness for clinical trial use during an ongoing BDBV outbreak - Focus on identifying successful candidates for further development and outbreak response - End goal is to enable clinical trial use of investigational BDBV vaccines and support outbreak response

Description

The Office of Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) seeks to use the Rapid Response Partnership Vehicle (RRPV) Consortium, an enterprise partnership in collaboration with industry and academia to facilitate research and development activities as follows:

The purpose of this RPP is to advance investigational BDBV vaccine candidates leveraging the VSV vaccine platform, which has demonstrated single dose protection in past EBOV outbreaks.

Work includes manufacturing process development through production of initial current Good Manufacturing Practice (cGMP) Phase 1 clinical trial material (CTM), with a goal of up to 10,000 doses. Early regulatory engagement will inform the critical-path IND-enabling nonclinical. The proposed approach must describe how any available platform efficiencies from prior or ongoing platform development and manufacturing to accelerate the path towards cGMP CTM production and IND submission under the U.S. FDA. Additional activities include a Phase 1 safety and immunogenicity trial as well as options for production of up to 100,000 doses of cGMP CTM.

The end goal of this effort is (1) to produce cGMP CTM and meet regulatory requirements to enable use of investigational candidate(s) in a clinical trial for the ongoing 2026 BDBV outbreak and (2) to identify successful BDBV vaccine candidates for potential further development.

Please see the attachments for more information. 

Questions are due June 16, 2026 by 12 p.m. Eastern. Proposals are due by June 26 at 3 p.m. Eastern.

Submission link: https://www.rrpv.org/solicitation/bundibugyo-virus-outbreak-response-vaccines-bundivx/

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