Innovation for HIV Vaccine Discovery (R01 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), specifically through the National Institute of Allergy and Infectious Diseases (NIAID), has reissued a Notice of Funding Opportunity (NOFO) titled "Innovation for HIV Vaccine Discovery (R01 Clinical Trial Not Allowed)" to support high-risk, high-impact research that explores novel vaccine strategies aimed at preventing HIV acquisition or persistent infection. This grant initiative is designed to foster early-stage discovery research that significantly diverges from traditional approaches, embracing exploratory strategies that have not previously been tested. It emphasizes catalytic advancements by leveraging recent vaccine research developments, such as those encountered during the COVID-19 pandemic. The NOFO specifically supports investigator-initiated R01 applications that exclude clinical trials. It is structured to promote groundbreaking, foundational HIV vaccine research that necessitates a Go/No-Go decision model. By the end of Year 2, projects must meet clearly defined, quantifiable metrics to receive continued funding at full levels through Year 4. This requirement ensures that only projects demonstrating promising results in early phases proceed with full support. Applications must focus on original concepts with the potential to impact vaccine immunogen or immunization strategy design. Relevant areas include novel mechanisms of immune response induction, innovative delivery platforms, exploration of underused viral targets, and incorporation of advanced tools such as omics and AI/machine learning. The use of animal models, especially nonhuman primates (NHPs), is encouraged, provided sex as a biological variable is considered. Applications involving traditional vaccine development pathways or lacking Go/No-Go criteria will not be reviewed. Eligible applicants span a wide array of organizations, including higher education institutions, nonprofits, for-profits, local and state governments, tribal governments, and foreign entities. The NOFO does not require cost-sharing. Applications must adhere strictly to NIH submission procedures via ASSIST, Grants.gov, or institutional systems, and comply with SF424 (R&R) Application Guide instructions. All required registrations (SAM, UEI, eRA Commons, Grants.gov) must be completed in advance. The NOFO outlines a structured review process, focusing on significance, innovation, investigator capability, methodological approach, and environment. Specific attention is given to the novelty of the vaccine strategy and the scientific justification for its potential efficacy. Awards are expected to begin as early as March 2026 for applications submitted by August 1, 2025. The program anticipates issuing 2 to 4 awards with a total of $2 million in funding for fiscal year 2024. For inquiries, scientific questions should be directed to Dr. Anjali Singh at anjali.singh@nih.gov or 301-592-7926. Financial questions may be addressed to Robert Kirker at robert.kirker2@nih.gov or 301-451-3176. Additional guidance is available through the NIH Office of Extramural Research and eRA Service Desk.