Clinical Studies of Infectious Agents, Vaccines and Antivirals in Adult and Pediatric Human Subjects

The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking clinical research services to conduct studies on infectious agents, vaccines, and antivirals involving adult and pediatric human subjects. The primary objectives include investigating the safety, immunogenicity, and protective efficacy of vaccines against various viruses such as pneumoviruses, paramyxoviruses, influenza, flaviviruses, alphaviruses, and emerging viruses like Zika and norovirus. Potential contractors must demonstrate capabilities in vaccine research, including USP-compliant pharmacy services, BSL-1/2 facilities, temperature-controlled storage, specimen processing, and robust data management systems. The sources sought notice requires capability statements limited to 5 pages, due by January 30, 2025 at 3:00 PM EST, which must comprehensively detail relevant experience, staff qualifications, and facility capabilities. Evaluation will likely focus on technical expertise, research infrastructure, and proven experience in conducting complex vaccine and infectious disease clinical trials.

The pre-solicitation notice indicates this will be a single-award Indefinite Delivery/Indefinite Quantity (IDIQ) contract with an anticipated 7-year period from August 2026 to August 2033. The contract follows the current arrangement with Johns Hopkins University and will encompass three primary task areas: pediatric vaccine studies (up to 400 infants/children annually), adult vaccine studies (400 adults annually), and challenge/pathogenicity research for adult inpatients (60 adults annually). There is no specific set-aside designation for small businesses, though the sources sought notice suggests interest in understanding small business capabilities. While no specific budget range is provided, the comprehensive nature of the research and the multi-year timeline suggests a substantial contract value. The research will support ongoing vaccine development efforts targeting critical viruses like influenza, respiratory syncytial virus (RSV), dengue, and Zika, building on previous successful vaccine development work in Brazil, India, Bangladesh, and the United States.