NIAID recently reissued the notice of funding opportunity (NOFO) HIV Vaccine Research and Design (HIVRAD) Program (P01, Clinical Trial Not Allowed). For nearly a decade, the HIVRAD Program has been advancing knowledge towards improved concepts, tools, and technology in HIV vaccines. It has acted as the bridge between innovation and product development for experimental clinical trials and actual Phase I clinical trials.
Apply if you seek support for multi-component, multidisciplinary projects that address scientific questions relevant to AIDS prophylactic vaccine discovery research.
Past HIVRAD Accomplishments
The HIVRAD Program actively helped to identify envelope glycoproteins showing good antigenicity as well as good manufacturability in clinical trials. HIVRAD has supported clade C protein manufacturing.
The mechanism of unconventional T-cell vaccine mediated protection of animals was decoded with the help of HIVRAD funding. HIVRAD concepts of stabilizing the HIV envelope by substituting proline and structure-based immunogen design helped inform development of the COVID vaccine.
For additional background information, see HIV Vaccine Development.
What’s Next for HIVRAD
Despite notable progress made in treating and preventing HIV infection with antiretroviral drugs, new HIV infections continue at an unacceptable rate. Developing a safe and effective HIV preventive vaccine remains a critical public health need.
Preventive vaccine development will require multiple approaches—isolating multiple potent broadly neutralizing antibodies from individuals living with HIV, generating native-like HIV envelope proteins, structural analysis of immunogens and antibodies at the atomic level, advanced understanding of human immunobiology, exploring alternate animal models, incorporating multidisciplinary technologies, and developing novel assays.
This NOFO will support research projects like:
- Approaches to elicit durable and broadly adaptive immunity against HIV and/or SIV.
- Identifying correlates of vaccine-induced immune protection against infection with HIV and/or SHIV/SIV in preclinical models.
- HIV structural studies as they relate to designing HIV immunogens.
- Improved animal model systems to address vaccine immunogenicity and/or efficacy.
- Approaches to improve the immunogenicity of HIV antigens (e.g., novel adjuvants and delivery systems).
- Novel candidate vaccine design for addressing the heterogeneity of HIV.
- Developing or improving vaccine vectors.
- Determining how immune cells can be mobilized to relevant mucosal sites.
- Investigations into innate immunity to alter the outcome of infection.
Your application should lay out a research plan with clear decision points. Include hypothesis-supporting data that demonstrate your research has advanced past the exploratory stage, including preliminary immunogenicity to justify vaccine candidate development.
Preclinical evaluation of vaccine concepts in nonhuman primates or small animal models, such as transgenic humanized mice, may be included.
Conversely, if you include the following types of studies, we will consider your application nonresponsive and not review it:
- Clinical trials (although use of existing clinical samples is permitted)
- Studies focused solely on therapeutic vaccines
- Studies focused on repeating or expanding HIV vaccine approaches that failed in efficacy trials
- Applications lacking immunogenicity data for prophylactic vaccine platforms
Other Application Elements
Research programs funded under this NOFO will be comprised of multiple components:
- Administrative Core: provides the overall management, coordination, and supervision of the Program. This Core administers the plan provided in the application to address long- and short-term management of the Program.
- Research Projects: Each application must propose a minimum of two Research Projects. Each Project must be well integrated into the Program overall.
- Scientific Core(s): One or more optional Scientific Cores may be proposed as a resource to the Program, and each of the proposed Cores must support at least two Projects.
The Administrative Core will coordinate an annual meeting for all Key Personnel, the Scientific Advisory Board, and NIAID staff to review goals and milestones achieved during the year, problems encountered, and external events that may influence the direction of work in following years.
Your application must also include a Plan for Enhancing Diverse Perspectives (PEDP), as detailed in Section IV. Application and Submission Information. Submit the PEDP under Other Project Information as an attachment. The PEDP will be assessed as part of the scientific and technical peer review evaluation and considered with respect to funding decisions.
Award Information
NIH intends to fund one or two awards in fiscal year 2025.
Your application’s budget request should not exceed $2.5 million in annual direct costs. The scope of your proposed project should determine the project period, with a maximum period of 5 years.
Applications are next due on March 13, 2024; and subsequently on March 13, 2025, and March 13, 2026.
If you have any questions, contact NIAID’s Dr. Bimal Chakrabarti at bimal.chakrabarti@nih.gov or 240-627-3385. Direct inquiries related to peer review to Dr. Barry Margulies at barry.margulies@nih.gov or 301-761-7956.