RFA-AI-20-036: Martin Delaney Collaboratory for Pediatric HIV Cure Research (UM1 Clinical Trial Not Allowed)
Slots: Only one application per institution is allowed to either this FOA or RFA-AI-20-035.
Internal Deadline: August 21, 2020, noon PT
LOI: November 6, 2020
External Deadline: December 7, 2020
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: 1
Anticipated Amount: Application budgets are limited to $3.5M in direct costs per year and need to reflect the actual needs of the proposed project. The total project period must be 5 years.
Who May Serve as PI: Standard NIH eligibility requirements.
Process for Limited Submissions: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://research.usc.edu/usc-grants/.
Materials to submit include:
(1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
(2) CV – (5 pages maximum)
Purpose: The objective of this FOA is to support a highly collaborative and synergistic research program focused on the development of research strategies suitable for pediatric populations to achieve either a sustained viral remission or complete eradication of persistent HIV reservoirs. Applications should support academic, industry, government, and community collaboration and partnerships.The application must include at least one private sector entity (defined below) to facilitate rapid translation of basic discovery research into therapeutic development and testing. The awardee will also be required to communicate and collaborate with the awards made under the companion Martin Delaney Collaboratory program. The proposed research should be innovative and must include a combination of basic, clinical, and applied research.
Examples of areas of research interest include, but are not limited to:
- Characterization of host factors, viral molecular processes and pathways influencing reservoir establishment, maintenance, and elimination in HIV-infected children.
- Evaluation and understanding of the role of the developing immune system in HIV persistence throughout infancy into young adulthood (0 to 24 years old).
- Characterization of the size, dynamics, distribution, and evolution of viral reservoirs in infants, children, adolescents and young adults in both peripheral blood and tissues.
- Characterization of timing of establishment, mechanisms of persistence and strategies to target CNS reservoirs in pediatric populations.
- Development, evaluation and validation of novel technologies, as well as novel application of existing technologies for latent reservoir characterization in pediatric populations. These may include novel molecular or culture-based assays or bioimaging.
- Development, evaluation and validation of surrogate biomarkers for monitoring the reservoir and evaluation of the impact of reservoir-targeted interventions, including identification of biomarkers for post-treatment control in children.
- Development and preclinical evaluation of a robust pipeline of promising cure strategies for pediatric populations.
- Animal model optimization for pediatric studies of HIV/SIV persistence.
- Community engagement, research literacy, and qualitative research relevant to community perspectives on and engagement in cure research in children with HIV and the impact on caregivers including assessment of acceptability, preferences, attitudes and perceptions related to cure research strategies in children.
- Non-invasive imaging to characterize tissue reservoirs in pediatric populations, including the CNS.
- Research involving human specimens collected from ongoing studies including observational trials, cohorts, or from specimen biobanks
- International collaborations are encouraged; this can include but is not limited to access to international pediatric participants and use of pediatric samples from international sites.
- Applications that include characterization of reservoirs in the central nervous system, including non-invasive imaging and/or cells of the myeloid lineage, and the impact of interventions on viral rebound in this compartment will be considered for co-funding by NIMH.
- Applications that include characterization of the influence of in utero exposure to addictive substances on HIV infection, reservoir establishment and maintenance in infants will be considered for co-funding by the National Institute of Drug Abuse (NIDA).
Target population for this FOA
Target populations include children, adolescents, and young adults living with HIV with perinatal infection age from birth up to 24 years of age. Children who initiated ART very early (within the 1st week of life) are of particular interest and access to this population is required.
Examples of anticipated outcomes/goals from the collaborative research:
- Identification of viral and immune targets leading to development of reservoir-targeting strategies and strategies for sustained control of viral rebound suitable for pediatric populations
- Characterization of effects of existing reservoir targeting agents in pediatric animal models leading to a pipeline of interventions ready for clinical evaluation in pediatric populations
- Pediatric-friendly assays and tools, including biomarkers, that accurately measure the effect of reservoir-targeting strategies or predict viral rebound or control and are scalable for use in clinical trials
- Greater understanding of CNS reservoirs, their characterization and targeting
- Knowledge to inform optimization of therapeutic and cure strategies for pediatric populations with a history of exposure to addictive substances
- Strengthened community involvement and partnership to guide design and conduct of future clinical trials in pediatric populations
The research proposed is expected to push the boundaries of what is currently feasible, and it is recognized that aspects of the plan necessarily will include high-risk research or development of improved methodology and technology. Development of combination treatment strategies or gene therapy approaches would be particularly suitable for this FOA.
Budgetary Requirements: This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.