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Optimal T-cell support for HIV neutralizing antibody induction to fusion peptide-inclusive regimens (Opti-FliP)

Award Number: P01AI181044
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/17/2024
PERIOD OF PERFORMANCE END DATE: 11/30/2029

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Optimal T-cell support for HIV neutralizing antibody induction to fusion peptide-inclusive regimens (Opti-FliP) - This HIVRAD program will develop an HIV vaccine regimen that is based on cooperative interactions between Env fusion peptide (FP)-directed antibodies and follicle-homing helper and cytotoxic T cells. We will use innovative vaccine modalities and adjuvants that are designed to elicit high-quality T cells in support of anti-FP antibodies. Strategies for eliciting broadly neutralizing antibodies (bnAbs) against HIV have made substantial progress. There are indications that germline targeting, divided doses, mRNA vaccination, and other strategies may all contribute to the goal of reliably eliciting bnAbs in humans. If these strategies are successful, however, the elicited bnAbs will likely be of lower titer than required to protect against HIV. An effective vaccine will therefore elicit a concomitant high-quality T-cell response, in addition to bnAbs. The proposed research program combines investigation of cooperative antibody and T-cell responses in people with testing innovative tools for eliciting helper and cytotoxic T cells that are distinguished, not by magnitude, but rather by longevity, localization to B-cell follicles, functional effector functions and/or avidity. Project 1 will examine humoral responses and follicular T cells in human beings receiving combined SOSIP/HTI vaccines, and will examine the anti-FP responses that contribute to effective HIV neutralization in clade C-infected people. Project 2 will leverage IL-10 inhibitors to safely elicit high-quality CD8+ T cells—and will then selectively boost cells of higher avidity. Project 3 will use immunogens that are targeted to Tf cells and/or mucosal surfaces to elicit anti-FP bnAbs that are supported by high-intensity Tf responses. As a culmination, P3 will also integrate information from all program components to test a new “cooperative” vaccine regimen in macaques. A shared objective of our program is to test the influence of pre-existing Tf responses on humoral responses to vaccination, and examine if CD8+CXCR5+ T cells contribute meaningful helper function. A second major objective is to evaluate the importance of T-cell avidity for both follicular-helper and cytotoxic functions. A third collective goal is to understand how FP-directed antibodies contribute to protective breadth against clade-C HIV envelopes.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $3,800,418 )
2026	2026	UNIVERSITY OF CALIFORNIA, DAVIS	1850 RESEARCH PARK DR STE 300	DAVIS	CA	95618	YOLO	USA	Allergy and Infectious Diseases Research	000	2	3/30/2026	NON-COMPETING CONTINUATION	$3,289,342
2026	2026	UNIVERSITY OF CALIFORNIA, DAVIS	1850 RESEARCH PARK DR STE 300	DAVIS	CA	95618	YOLO	USA	Allergy and Infectious Diseases Research	001	2	4/13/2026	SUPPLEMENT FOR EXPANSION	$511,076
														Subtotal = $3,800,418

Issue Date FY: 2025 ( Subtotal = $3,552,620 )
2025	2025	UNIVERSITY OF CALIFORNIA, DAVIS	1850 RESEARCH PARK DR STE 300	DAVIS	CA	95618	YOLO	USA	Allergy and Infectious Diseases Research	001	1	1/17/2025	NEW	$0
2025	2025	UNIVERSITY OF CALIFORNIA, DAVIS	1850 RESEARCH PARK DR STE 300	DAVIS	CA	95618	YOLO	USA	Allergy and Infectious Diseases Research	000	1	12/17/2024	NEW	$3,552,620
														Subtotal = $3,552,620

Grand Total All Awards = $7,353,038

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Optimal T-cell support for HIV neutralizing antibody induction to fusion peptide-inclusive regimens (Opti-FliP)

Award Number: P01AI181044

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/17/2024

PERIOD OF PERFORMANCE END DATE: 11/30/2029

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