The scientific objective of NIAID’s new notice of funding opportunity (NOFO) Mechanisms of Inducing HIV Immunity in Early Life (MIEL) (U01, Clinical Trial Not Allowed) is to support hypothesis-driven basic and applied research to investigate and advance the mechanistic understanding on how immune ontogeny and functionality in early life could be harnessed in the context of HIV vaccines and broadly neutralizing antibodies (bNAbs) to protect against acquisition of HIV infection.
The initiative focuses on neonates, infants, and pre-adolescents age groups (from birth to less than 12 years of age) considering that the unique and less pre-programmed immune landscape of early life may present an advantage to target HIV prevention strategies for elicitation of anti-HIV immune responses.
Key areas of research focus include: 1) evaluation of pediatric HIV immunization strategies to identify prime components and pathways of immune ontogeny and functionality for the development of early and poly-specific bNAb lineages and 2) determination of the biodistribution and efficacy of prophylactic bNAbs in the evolving pediatric immune landscape.
Example research topics include:
- Mechanisms for establishing and maintaining immunity to HIV in early life, including active and passive immunization strategies in pediatric populations exposed- or unexposed- to HIV.
- Role of maternal influence, through breastfeeding, on immune ontogeny and clinical outcomes to HIV prophylactic measures in early life, including maternal determinants e.g., HIV infection status, antiretroviral therapy initiation, bNAbs treatment, inflammatory milieu, microbiota, and antibodies profile.
- Developmental pathways of bNAbs to HIV during pediatric immune maturation.
- Impact of vaccine adjuvants as immunopotentiators for improving pediatric immunity to HIV.
- Longitudinal imaging of pediatric immune cell dynamics and functionality in response to HIV immunization strategies.
- Developmental pathways of bNAbs to HIV during pediatric immune maturation.
- Mechanisms of elicitation of tissue-specific and/or mucosal immunity to HIV in the context of early life host microbiota and evolving immune landscape.
- Impact of vaccine adjuvants as immunopotentiators for improving pediatric immunity to HIV.
- Molecular regulators of pediatric HIV immunity based on systems-level identification of biomarkers of safety and efficacy of immunization with HIV prophylactic vaccines and bNAbs.
Applications may include basic and applied research using human samples and/or nonhuman primate (NHP) animal models. Research programs are encouraged to include multidisciplinary teams to interrogate immunological and virological challenges of developing safe and effective HIV vaccines and bNAbs.
Note that applications proposing the following studies or topic areas will be considered nonresponsive and will not be reviewed:
- Clinical trials.
- Studies on human age groups 12 years or older.
- Studies based on HIV infected pediatric populations or cohorts with other immunodeficiencies or genetic diseases.
- HIV cure or treatment interventions.
- Strategies evaluating non-immune mechanisms of developing and maintaining immunity to HIV in early life.
- Vaccines and bNAbs for targets other than HIV.
- Use of animal models other than NHPs.
- Animal model development.
- Vaccines or bNAb platform development.
- Epidemiological studies.
As part of this initiative, awarded principal investigators will form a Steering Committee and an External Scientific Advisory Board (ESAB). Those entities are further described in the NOFO. Note that potential ESAB members must not be named in the application or contacted prior to any awards being made.
Award Budget
Application budgets must reflect the actual needs of the proposed project and the direct costs are not expected to exceed $750,000 in a year. The maximum project period is 5 years.
We intend to fund three or four awards in fiscal year 2025.
The deadline to apply is October 9, 2024, at 5 p.m. local time of the applicant organization.
Key Contacts
If you have questions, contact NIAID’s Dr. Anjali Singh at anjalisingh@niaid.nih.gov or 240-507-4924. For matters related to peer review, reach out to Dr. Samita Andreansky at samita.andreansky@nih.gov or 240-669-2915.