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Messenger RNA Immunogens for initiation of protective HIV non-neutralizing antibodies

Award Number: U19AI142596
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: 01/11/2019
PERIOD OF PERFORMANCE END DATE: 12/31/2025

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Messenger RNA Immunogens for initiation of protective HIV non-neutralizing antibodies - While HIV-1 broadly neutralizing antibodies (bnAbs) provide potent protection from HIV-1, to date they have been difficult to induce in the setting of vaccination. A second type of HIV-1 envelope (Env) antibodies that are easy to induce are termed non-neutralizing antibodies (NNAbs) (because they are not bnAbs), or called effector antibodies, because they mediate a myriad of potentially protective anti-HIV-1 effector mechanisms. One of the 5 Phase IIb HIV-1 vaccine efficacy trials (ALVAC/AIDSVAX in RV144) showed an estimated vaccine efficacy of 31%, with a correlate of decreased transmission risk of polyfunctional antibodies that mediate FcR-anti-HIV-1 activities including C1 and V2-targeted ADCC. Currently there are two vaccine efficacy trials ongoing to test the ability of an ALVAC-C, bivalent C/C gp120 boost (HVTN 702) and rAd26 prime, gp140 protein boost (HVTN 705) with hopes of inducing protective NNAbs. HVTN 702 has two wildtype (WT) gp120 Envs as boosts, and HVTN 705 has one WT Env as boost. However, neither trial utilitize strategies for inducing a breadth of NNAbs with boosting Env design. Thus, a key goal of current HIV-1 vaccine development is to develop the simplest and most effective vaccine that induces polyfunctional NNAbs should either of the current efficacy trials fail to improve on RV144. Our overall goals are 1) to develop an ADCC mosaic multivalent Env immunogen to follow an ALVAC-C prime; and 2) to produce ADCC mosaic Env gp120s under current good manufacturing practices (CGMP) conditions, perform toxicity studies, and prepare an investigational new drug application (IND) for testing in an HVTN Phase I clinical trial in man. Overall Specific Aim 1. Develop and produce a trivalent ADCC mosaic Env immunogen that can follow an ALVAC-C prime and test them in the Animal Core in an ADCC mediating NNAb-unmutated common ancestor (UCA) VH + VL mouse model and in a transmitted/founder (TF) tier 2, R5 SHIV rhesus macaque study (RMs) (Drew Weissman, Project Lead; Barton Haynes, Co-I) Overall Specific Aim 2. Produce CGMP trivalent ADCC mosaic mRNA gp120 immunogens. (Thomas Denny Project Lead; Maureen Maughan, Project Co-I) .


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 = $0 )
2025	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	000	5	12/12/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $3,846,023 )
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	001	5	4/24/2024	NON-COMPETING CONTINUATION	$384,603
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	000	5	12/15/2023	NON-COMPETING CONTINUATION	$3,461,420
														Subtotal = $3,846,023

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	001	4	6/12/2023	NON-COMPETING CONTINUATION	$0
2023	2022	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Allergy and Infectious Diseases Research	000	4	2/24/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $3,878,223 )
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	4	1/6/2022	NON-COMPETING CONTINUATION	$3,878,223
														Subtotal = $3,878,223

Issue Date FY: 2021 ( Subtotal = $3,846,345 )
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	001	3	3/10/2021	NON-COMPETING CONTINUATION	$1,700,000
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	3	2/17/2021	NON-COMPETING CONTINUATION	$2,146,345
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	002	3	3/29/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $3,846,345

Issue Date FY: 2020 ( Subtotal = $3,798,808 )
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	002	2	4/21/2020	NON-COMPETING CONTINUATION	$0
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	001	2	4/2/2020	NON-COMPETING CONTINUATION	$0
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	2	1/17/2020	NON-COMPETING CONTINUATION	$3,798,808
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	003	2	5/11/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $3,798,808

Issue Date FY: 2019 ( Subtotal = $3,659,615 )
2019	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	002	1	1/16/2019	NEW	$0
2019	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	000	1	1/10/2019	NEW	$3,974,417
2019	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Allergy and Infectious Diseases Research	001	1	1/14/2019	NEW	-$314,802
														Subtotal = $3,659,615

Grand Total All Awards = $19,029,014

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Messenger RNA Immunogens for initiation of protective HIV non-neutralizing antibodies

Award Number: U19AI142596

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: 01/11/2019

PERIOD OF PERFORMANCE END DATE: 12/31/2025

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