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Induction of protective antibodies for HIV vaccine development

Award Number: UM1AI144371
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/15/2019
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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Induction of protective antibodies for HIV vaccine development - This Consortium for HIV/AIDS Vaccine Development (CHAVD) will apply state-of-the-art technologies and immunologic tools to focus on iterative, rational vaccine design that will lead to a successful final vaccine design. Much work in previous years has led to this critical juncture in HIV-1 vaccine development where the route forward has become clearer to a protective HIV-1 vaccine. The rationale for this grant is that the first 13 years of the Center for HIV/AIDS Vaccine Immunology programs defined the roadblocks preventing a vaccine, developed first generation HIV-1 immunogens to induce HIV-1 protective antibodies and established a translational pipeline to accelerate HIV-1 vaccine development. The overall goal of this grant is to develop an effective HIV-1 vaccine for global use. There are two foci proposed in the CHAVD: Focus 1, strategies for induction of HIV-1 broadly neutralizing antibodies (bnAbs), and Focus 2, strategies for induction of protective HIV-1 non-neutralizing antibodies. In Focus 1, our overall goal is to design Env immunogens that will elicit multiple specificities of bnAbs. Here the CHAVD team will design immunogens that induce bnAbs, induce optimal CD4 T cell help for bnAb induction, transiently down-modulate constraints from negative regulatory cells and immune tolerance mechanisms, and allow for disfavored bnAb B cell lineages to develop. In Focus 2, our overall goal is to develop multivalent immunogens that induce broad and potent protective non- neutralizing HIV-1 antibodies (NNAbs). The Management and Operations Unit will oversee the CHAVD translational pipeline, and each of our six Science Research Support Units (SRSUs) will provide key elements of immunogen design or pre-clinical evaluation of candidate immunogens. Once designed and tested in bnAb knock-in mice or in macaques, promising vaccine candidates that pass our go-no go criteria will be vetted by the CHAVD Scientific Product Development Committee and DAIDS, then produced for clinical trials in our GMP Production Unit at Duke and tested in Phase I trials by the HIV Vaccine Trials Network. Our Clinical Trials Sample Analysis Unit will determine the immunogenicity achieved and provide feedback on immune responses induced in man to Focus 1 or Focus 2 and our SRSUs for iterative improvement of immunogens. We expect that by the end of this grant, a final vaccine candidate will be delivered to the NIAID that has reproducibly induced durable levels of either bnAbs or protective NNAbs in rhesus macaques (RMs) or in a Phase I trial in humans, or in both.


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: 2025 ( Subtotal = $20,752,000 )
2025	2025	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	002	7	6/20/2025	NON-COMPETING CONTINUATION	$20,752,000
2025	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	001	6	2/13/2025	NON-COMPETING CONTINUATION	$0
2025	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	000	6	10/9/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $20,752,000

Issue Date FY: 2024 ( Subtotal = $36,217,089 )
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	006	6	8/7/2024	SUPPLEMENT FOR EXPANSION	$3,192,992
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	003	6	7/24/2024	SUPPLEMENT FOR EXPANSION	$3,169,510
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	005	6	8/6/2024	SUPPLEMENT FOR EXPANSION	$2,741,630
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	004	6	7/25/2024	SUPPLEMENT FOR EXPANSION	$809,741
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	002	6	7/8/2024	NON-COMPETING CONTINUATION	$21,000,000
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	007	6	8/14/2024	SUPPLEMENT FOR EXPANSION	$5,303,216
2024	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	001	5	1/17/2024	NON-COMPETING CONTINUATION	$0
2024	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	000	5	11/2/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $36,217,089

Issue Date FY: 2023 ( Subtotal = $30,401,371 )
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	002	5	6/29/2023	NON-COMPETING CONTINUATION	$20,999,999
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	003	5	8/2/2023	NON-COMPETING CONTINUATION	$9,401,372
2023	2022	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	000	4	3/28/2023	NON-COMPETING CONTINUATION	$0
2023	2022	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	001	4	4/26/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $30,401,371

Issue Date FY: 2022 ( Subtotal = $27,892,292 )
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	002	4	7/28/2022	NON-COMPETING CONTINUATION	$6,528,199
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	001	4	6/29/2022	NON-COMPETING CONTINUATION	$21,000,000
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	003	4	8/10/2022	NON-COMPETING CONTINUATION	$364,093
2022	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	3	5/11/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $27,892,292

Issue Date FY: 2021 ( Subtotal = $27,785,406 )
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	002	3	8/4/2021	NON-COMPETING CONTINUATION	$3,222,046
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	004	3	9/1/2021	NON-COMPETING CONTINUATION	$0
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	003	3	8/26/2021	NON-COMPETING CONTINUATION	$3,563,360
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	001	3	7/13/2021	NON-COMPETING CONTINUATION	$21,000,000
2021	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	2	3/23/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $27,785,406

Issue Date FY: 2020 ( Subtotal = $26,347,892 )
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	004	2	9/14/2020	NON-COMPETING CONTINUATION	$50
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	002	2	8/7/2020	NON-COMPETING CONTINUATION	$21,000,000
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	003	2	8/26/2020	NON-COMPETING CONTINUATION	$5,347,842
2020	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	001	1	4/8/2020	NEW	$0
2020	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	1	3/31/2020	NEW	$0
														Subtotal = $26,347,892

Issue Date FY: 2019 ( Subtotal = $21,000,000 )
2019	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	1	7/15/2019	NEW	$21,000,000
														Subtotal = $21,000,000

Grand Total All Awards = $190,396,050

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Induction of protective antibodies for HIV vaccine development

Award Number: UM1AI144371

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 07/15/2019

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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