Clinical Trial Design and Execution (Phase 1)

The contract involves the design and execution of Phase 1 clinical trials to evaluate the safety, appropriate dosage, and initial immunogenicity of pandemic influenza vaccine candidates in human subjects. It is a subcontract opportunity issued by the Department of Health and Human Services through the Barda division, with a focus on advancing vaccine development during a public health emergency. The solicitation was posted on June 3, 2026, with a response deadline set for July 15, 2026. The work is to be performed in Washington, DC, under the NAICS code 541711, which pertains to research and development in biotechnology. The contract emphasizes the early-stage clinical evaluation critical to moving pandemic influenza vaccines forward toward regulatory approval and widespread use.