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.Apply for RFA AI 24 029
- 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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Frequently Asked Questions (FAQs): Mechanisms of Inducing HIV Immunity in Early Life (MIEL) - RFA-AI-24-029
1) What is the MIEL funding opportunity (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 that supports 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.
2) What type of NIH award mechanism is this?
This opportunity uses the U01 mechanism, which is a cooperative agreement. That means the NIH is expected to have substantial programmatic involvement during the project period, and awardees should be prepared for a more collaborative relationship with NIH than with a standard research grant.
3) What is the main scientific focus of this NOFO?
The central focus is understanding the biological and immunological mechanisms that shape early-life protection against HIV, including how immune protection is formed, how it changes over time, and how it is maintained in infants and young children.
4) What age range does this opportunity cover?
The research focus is pediatric immunity from birth up to (but not including) 12 years of age.
5) Are clinical trials allowed under this funding opportunity?
No. This opportunity is explicitly marked as "Clinical Trial Not Allowed." Projects should not be designed as clinical trials and should instead emphasize mechanistic, observational, translational, or preclinical research that explains how immune protection works in the targeted pediatric age group.
6) What kinds of prevention approaches are specifically highlighted?
The NOFO highlights preventive approaches such as prophylactic vaccination and the use of broadly neutralizing HIV antibodies (bNAbs), with an emphasis on understanding how these approaches influence protection from acquiring HIV infection in early life.
7) What kinds of research questions does NIH want addressed?
Projects are expected to clarify the "how" and "why" behind early-life HIV immunity, such as:
- Which immune components are most protective in infants and young children
- How immune pathways engaged in early life contribute to protection
- How immune memory and durability are formed in children
- How antibody-based prophylaxis (including bNAbs) interacts with the developing immune system
- How maternal factors or early exposures shape immune development
- What immune signatures might predict durable protection after pediatric-oriented vaccination strategies
8) What is NIH ultimately trying to achieve through this program?
The intent is to generate actionable mechanistic knowledge that can guide future prevention tools for children, including next-generation pediatric HIV vaccines and antibody-mediated prevention approaches, while keeping the work within a non-clinical-trial scope for this specific announcement.
9) What is the activity category for this opportunity?
The activity category is Health.
10) What is the CFDA listing associated with this announcement?
The CFDA listing associated with this funding opportunity is 93.855.
11) Who is eligible to apply?
The NOFO is open to a wide range of applicant types, including:
- 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
- Small businesses
- Eligible federal agencies
- Regional organizations
- U.S. territories or possessions
- Non-U.S. entities (foreign organizations)
12) Are specific institution types encouraged or called out as eligible?
Yes. The announcement 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), and faith-based or community-based organizations.
13) Are foreign organizations allowed to apply?
Yes. Non-U.S. entities (foreign organizations) are listed among the eligible applicant types, suggesting NIH is open to global collaboration when scientifically appropriate.
14) What is the application due date?
The original application due date listed is 2024-10-09.
15) What is the maximum award amount (ceiling)?
The award ceiling is $750,000, indicating the maximum budget level NIH expects to support per award under this announcement.
16) Does the opportunity state how many awards NIH expects to make?
The provided opportunity summary does not specify the anticipated number of awards.
17) How should applicants think about budgeting under this NOFO?
Applicants should treat the $750,000 ceiling as a practical upper limit and align budgets with clearly justified mechanistic research activities, rather than budgeting for clinical trial operations (since clinical trials are not allowed).
18) What makes pediatric HIV immunity a distinct focus compared with adolescent or adult immunity?
This NOFO emphasizes that immune responses and durability in infants and young children may differ from adolescents or adults, and it seeks mechanistic explanations for factors that uniquely enhance or limit the effectiveness of vaccines or antibody-based prevention in early life.
19) What kinds of outcomes or deliverables are implied for funded projects?
The implied deliverable is a stronger mechanistic foundation for pediatric HIV prevention, such as identifying immune pathways, immune memory features, and immune signatures associated with durable protection that can inform future pediatric vaccine and antibody-mediated prevention tool development.
20) What is the practical scope boundary applicants should keep in mind?
The boundary is that projects should focus on mechanism-focused research (mechanistic, observational, translational, or preclinical) explaining immune protection in children up to age 12, and should not be structured as clinical trials under this specific funding opportunity.
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