Bundibugyo Virus Outbreak Response Vaccines (BundiVx) - RRPV Consortium

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/