Mechanisms of Inducing HIV Immunity in Early Life (MIEL) (U01 Clinical Trial Not Allowed) | RFA AI 24 029

Opportunity Information: Apply for RFA AI 24 029

The Mechanisms of Inducing HIV Immunity in Early Life (MIEL) funding opportunity (RFA-AI-24-029) is a National Institutes of Health (NIH) cooperative agreement (U01) aimed at advancing basic and applied research on how immunity to HIV is established, develops over time, and is maintained in children from birth up to (but not including) 12 years of age. The central focus is on understanding the biological and immunological mechanisms that shape early-life protection against HIV, with particular attention to how preventive approaches such as prophylactic vaccination and the use of broadly neutralizing HIV antibodies (bNAbs) influence protection from acquiring HIV infection. This opportunity is explicitly marked as "Clinical Trial Not Allowed," meaning projects should not be designed as clinical trials; instead, they should concentrate on mechanistic, observational, translational, or preclinical research that can explain how immune protection works in this age group and how it might be improved.

Because this is a U01 cooperative agreement, awardees can expect a more collaborative relationship with NIH than under a standard research grant, with substantial programmatic involvement from the agency during the project period. The activity category is Health, and the CFDA listing associated with the announcement is 93.855. The overall intent is to generate actionable scientific knowledge about pediatric immune responses to HIV-relevant interventions, including what immune pathways are engaged in early life, how immune memory and durability are formed in children, and what factors might uniquely enhance or limit the effectiveness of vaccines or antibody-based prevention in infants and young children compared with adolescents or adults.

The NOFO is open to a wide range of applicant types, reflecting an interest in drawing from many sectors and communities. Eligible applicants include state, county, and local 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This broad eligibility suggests NIH is encouraging multidisciplinary participation and, where scientifically appropriate, global collaboration, especially given the international burden of pediatric HIV exposure and infection.

Key administrative details include an original application due date of 2024-10-09 and an award ceiling of $750,000. While the opportunity summary does not specify the anticipated number of awards in the provided text, the ceiling indicates the maximum budget level NIH expects to support per award under this announcement. Applicants should treat the ceiling as a practical upper limit when planning scope, staffing, and experimental aims, and should align their budgets with clearly justified mechanistic research activities rather than clinical trial operations.

In practical terms, competitive projects under this NOFO would be expected to clarify the "how" and "why" behind early-life HIV immunity: what immune components are most protective in infants and young children, how maternal factors or early exposures shape immune development, how antibody-based prophylaxis (including bNAbs) interacts with the developing immune system, and what immune signatures might predict durable protection following vaccination strategies intended for pediatric use. The deliverable NIH is pushing toward is a stronger mechanistic foundation that can guide future prevention tools for children, including next-generation pediatric HIV vaccines and antibody-mediated prevention approaches, without conducting clinical trials within the scope of this specific funding announcement.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Mechanisms of Inducing HIV Immunity in Early Life (MIEL) (U01 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): 93.855.
• This funding opportunity was created on 2024-06-18.
• Applicants must submit their applications by 2024-10-09. (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 $750,000.00 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.

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