A Multi-omics Approach to Immune Responses in HIV Vaccination and Intervention (P01 Clinical Trial Not Allowed) | RFA AI 22 038

Opportunity Information: Apply for RFA AI 22 038

The National Institutes of Health funding opportunity RFA AI 22 038, titled "A Multi-omics Approach to Immune Responses in HIV Vaccination and Intervention (P01 Clinical Trial Not Allowed)," is designed to fund large, multi-disciplinary program projects that use modern omics methods to deepen understanding of immune responses relevant to HIV prevention, therapeutic vaccination, and immunomodulatory cure strategies. The core idea is to bring together teams that can combine high-throughput biological measurements (omics), advanced computation, and targeted, hypothesis-driven laboratory experiments to explain how the immune system reacts to vaccines or cure-oriented interventions and to use those insights to improve future approaches.

This FOA emphasizes integrated, multi-component research rather than single, stand-alone studies. Applicants are expected to build coordinated projects that connect different scientific parts into a unified program, for example pairing systems-level profiling of immune responses (such as transcriptomics, proteomics, metabolomics, epigenomics, microbiomics, single-cell technologies, or other omics platforms) with computational modeling and follow-up experiments that test specific mechanistic hypotheses. The goal is not only to generate large datasets, but to translate those datasets into interpretable biological findings about immune pathways, correlates of protection, response signatures, or mechanisms that could guide the design or optimization of HIV vaccines and cure interventions.

The scientific scope covers both preventative and therapeutic directions. On the prevention side, projects may focus on immune responses to candidate HIV vaccines, seeking to identify immune signatures associated with stronger or more durable responses, to understand why some regimens perform better than others, or to clarify the immune features needed for protection. On the therapeutic and cure-intervention side, the FOA supports work that examines immune responses to strategies intended to control or eliminate HIV in people living with the virus, including immunomodulatory approaches aimed at achieving remission or functional cure. In all cases, the expectation is that omics and computational analyses will be tightly linked to experimental validation so that findings move beyond descriptive associations toward biological explanation.

The mechanism is a P01 (Program Project) grant, which generally supports a structured set of interrelated research projects organized around a central theme, often with shared resources or cores. The FOA explicitly states "Clinical Trial Not Allowed," meaning applicants should not propose studies that meet the NIH definition of a clinical trial under this announcement. The research can still involve clinical samples or data in a way that supports mechanistic and immunologic discovery, but it must remain within the boundaries of what NIH permits under a non-clinical-trial FOA.

Eligibility is broad and includes many types of domestic organizations: state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education when specified in the listing); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as eligible federal agencies and faith-based or community-based organizations. A U.S. territory or possession and regional organizations are also included in the eligibility discussion.

At the same time, the FOA draws clear lines around foreign participation. Non-domestic (non-U.S.) entities, described as foreign organizations and foreign institutions, are not eligible to apply as the applicant organization. Non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components as defined in the NIH Grants Policy Statement are allowed, meaning a U.S.-based applicant may include certain foreign collaborations or activities when structured as an approved foreign component within an otherwise domestic application, consistent with NIH policy.

Administratively, this is a discretionary grant opportunity offered by NIH within the education and health activity area, with CFDA numbers 93.279 and 93.855. The opportunity was created on 2022-05-27 and had an original closing date of 2022-10-13. The listed award ceiling is $1,000,000. The FOA indicates expected awards, but the specific number is not provided in the supplied text.

Overall, the announcement is aimed at teams that can do end-to-end systems immunology for HIV: generating multi-omics data on immune responses to vaccination or cure-oriented interventions, applying sophisticated computational analysis to extract meaning, and then using focused experiments to test and refine mechanistic interpretations. The intended outcome is actionable insight that can improve how HIV vaccines and immune-based interventions are designed, evaluated, and optimized.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "A Multi-omics Approach to Immune Responses in HIV Vaccination and Intervention (P01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279, 93.855.
• This funding opportunity was created on 2022-05-27.
• Applicants must submit their applications by 2022-10-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AI 22 038

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: