The purpose of NIAID’s new notice of funding opportunity (NOFO) Engineering Durable HIV Vaccine Responses (ENDURE) (R01, Clinical Trial Not Allowed) is to support basic and applied research to understand and improve durable immune responses to candidate HIV vaccines.
Through this NOFO, we aim to fund hypothesis-driven research to investigate and improve the durability of immune responses to candidate vaccines for HIV prevention. Apply if you can propose research to 1) understand and define durable vaccine responses; 2) develop or improve methods to measure durable vaccine responses; and/or 3) engineer more durable vaccine responses. While vaccine durability is ideally defined in terms of protection from disease, for the purposes of this NOFO, durability consists of persistent immune responses, recall responses, and/or adaptive immune memory.
Example research topics include:
- Comparisons of vaccine parameters to understand their effect on persistence of immune responses, including, but not limited to, antigen display, valence, route of delivery, and/or platform.
- Optimization of vaccine regimens, including prime-boost regimens, and parameters for induction and maintenance of immune responses.
- Induction of germinal centers, long-lived plasma cells, or other components of durable immune responses.
- Identification of immediate, early immune responses programming durable immune responses.
- Application of immediate, early immune responses to measuring or inducing durable immune responses.
- Identification of biomarkers, signatures, or predictors of durable immune responses.
- Development of assays and techniques, including methods for mucosal sampling, to measure durability of immune responses.
Conversely, your application should not propose the following, or we will consider your application nonresponsive and not review it:
- Clinical trials.
- Iterative immunogen optimization strategies solely focused on optimizing product immunogenicity.
- Strategies focused solely on increasing breadth of immunity.
- Host cell engineering (e.g., CAR T cells, gene editing, viral transduction).
- Antibody engineering, passive immunization, or administration of antibodies.
- HIV cure or treatment interventions.
- Vaccines for targets other than HIV, unless used for benchmarking.
- Durability of immune responses after infection, unless used for benchmarking.
Though clinical trials are not allowed, we encourage you to use samples from clinical trials funded through other mechanisms or collaborations with groups performing clinical trials. Studies in appropriate animal models, including small animals and nonhuman primates, with HIV, SIV, and/or SHIV are allowed.
Benchmarking durability using vaccines for infectious diseases other than HIV is allowed as appropriately justified. Applicants are encouraged to incorporate bioengineering approaches.
Be aware that you may request samples from the HIV Vaccine Trials Network (HVTN), Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections Network (ACTG), the International Maternal Pediatric Adolescent Clinical Trials Network (IMPAACT), and other sources.
Administrative Details
NIAID plans to fund up to four awards in fiscal year 2025.
Application budgets are not expected to exceed $750,000 in annual direct costs. The actual needs of your proposed project should determine the size of your budget request.
The scope of the proposed project should determine the project period. The maximum project period you may request is 5 years.
The deadline to apply is October 9, 2024, at 5 p.m. local time of the applicant organization.
Direct questions to Dr. Amy Palin at amy.palin@nih.gov or 240-627-3342. For concerns specific to peer review, reach out to Dr. Robert Unfer at robert.unfer@nih.gov or 240-669-5035.