Mumps Subunit and mRNA Vaccine Repeat Dose Toxicity Studies

Solicitation
Person of Contact Kelli D. Moss (kelli.moss@nih.gov)
Proposal Due Date Friday, November 7, 2025 (Closed 9 months ago)
  • Solicitation Status Awarded
  • Date Awarded
  • Research Category Research & Development Services & Subcontracts
  • Vendor Name Leidos Biomed
  • Solicitation Number S26-103
  • NCI OA Contract Number 75N91019D00024 – NCI-FFRDC

Description

The Vaccine Clinical Materials Program (VCMP) at the Frederick National Laboratory for Cancer Research, which supports the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Disease at the National Institutes of Health, is seeking support for two toxicology studies to evaluate the safety of a recombinant subunit Mumps vaccine (Study 1) and an mRNA Mumps vaccine (Study 2). VCMP is looking for a subcontractor who can perform an FDA-mandated safety analysis based on a separate repeat-dose toxicology study of each investigational vaccine. The studies must be conducted in accordance with U.S. Good Laboratory Practices (GLP) standards (21CFR58) and performed consistent with guidance in International Conference on Harmonization (ICH) M3(R2) and S6(R1) documents and other relevant guidance from FDA and ICH. The subcontractor shall perform testing according to standard operating procedures and approved study protocols to measure the toxicity of the vaccines when delivered with adjuvant intramuscularly in New Zealand White Rabbits. Toxicity is measured by multiple in-life parameters, gross pathology and histological analysis. Toxicokinetic evaluation is also requested as part of the mRNA vaccine study.

Proposal Instructions

Please contact Kelli D. Moss at kelli.moss@nih.gov for the full Request for Proposal. Questions are due by 2:00PM (ET) 10/24/2025; Proposals are due by 2:00PM (ET) 11/07/2025. A firm fixed price proposal is required for this project. Thank you.