NIAID will support integrated multi-project research programs applying emerging and improved technologies to develop innovative gene- or cell-based HIV cure approaches. You can apply through the notice of funding opportunity (NOFO) Cell and Gene Therapies for HIV Cure: Developing a Pipeline (P01, Clinical Trial Not Allowed).
We expect applicants to leverage recent insights into virus-host interactions, genotype and phenotype of HIV latent cells, and reservoir cell survival and proliferation in order to achieve sustained viral remission in the absence of antiretroviral treatment or elimination of HIV infection from the body.
Each P01 award will include a minimum of three synergistic individual research projects. Research goals and objectives could include:
- Strategies to apply advanced novel genome engineering technologies to target HIV provirus DNA or RNA—to excise, inactivate, or silence the expression of the integrated viral genome or modulate gene expression and protein function.
- Cell- or tissue-targeting methods to enable in vivo delivery of gene therapies.
- Developing allogeneic or universal “off the shelf” cell and gene therapeutics.
- Approaches to modulate immune responses that impact therapeutic efficacy and dosing, including methods to reduce immunogenicity of delivery vectors or transgenes, avoidance of pre-existing immunity, or minimize elicitation of anti-drug antibodies.
- Ex vivo or in vivo gene modification to render cells resistant to infection or enhance the immune system's ability to suppress viral expression or to eliminate HIV-infected cells.
- Novel methods to enhance transplantation and engraftment, or minimize rejection, of modified cells as part of an HIV-targeted transplantation strategy.
- Test-of-concept studies in appropriate animal models, including nonhuman primates.
Refer to the NOFO for examples of the study types listed above.
Your P01 application must also include a private sector partnership to facilitate development of strategies appropriate for future clinical studies and ultimately commercialization, e.g., biotechnology, pharmaceutical, bioengineering, stem cell, and chemical companies.
Include an administrative core in your application to provide management, coordination, and supervision of both the scientific and fiscal aspects of the overall program. You may include scientific cores to provide resources or facilities that are essential for the activities of two or more research projects.
You must provide a Milestone Plan and identify significant research outcomes, with timelines, to reflect planning and management of the overall program. NIAID staff will negotiate the milestones prior to award and may renegotiate them during the project period.
Prior Consultation
This is a complicated NOFO. We strongly encourage potential applicants to arrange a prior consultation with Dr. Betty Poon, our scientific/research contact for this initiative, at poonb@mail.nih.gov or 240-669-5024.
In the prior consultation, we can advise whether your proposed program meets the goals of this NOFO and discuss matters related to responsiveness.
Application Details
Request a project period that reflects the scope of your proposed project. The maximum project period you may request is 5 years.
Similarly, request a budget that reflects the actual needs of your proposed project. Your budget request is not expected to exceed $2.2 million in annual direct costs.
The deadline to apply is July 30, 2024, at 5 p.m. local time of the applicant organization.
Again, direct questions about this initiative to Dr. Betty Poon, whose contact details are listed above. For concerns related to peer review, reach out to Dr. Bruce Sundstrom at sundstromj@niaid.nih.gov or 240-669-5045.