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A clinical trial to evaluate the impact of broadly neutralizing antibody VRC01 on HIV viral reservoir and maintenance of suppression in a cohort of early-treated children in Botswana

Award Number: U01AI135940
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: 02/20/2018
PERIOD OF PERFORMANCE END DATE: 01/31/2027

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A clinical trial to evaluate the impact of broadly neutralizing antibody VRC01 on HIV viral reservoir and maintenance of suppression in a cohort of early-treated children in Botswana - The Dual bNAb Treatment in Children Study (“Tatelo”) is an ongoing phase I/II, multi-site clinical trial of dual treatment with two broadly neutralizing monoclonal antibodies (bNAbs), VRC01LS and 10-1074, offered to HIV-1 infected virally suppressed children. The study is evaluating the efficacy of dual bNAbs for maintaining viral suppression in the absence of ART among virally suppressed HIV-infected children who started standard ART within 96 hours of birth (or soon after intrapartum infection). All children in the Tatelo Study were recruited from the Early Infant Treatment (EIT) study (U01AI114235), and have been followed from birth with frequent assessments of their clinical, virologic and immunologic characteristics. Children who received at least 96 weeks of ART and met virologic entry criteria were offered enrollment into the Tatelo Study. The intervention consisted of two PK and safety phases (single and then dual bNAbs), followed by the main study intervention (dual bNAbs plus ART for at least 8 weeks, then dual bNAbs alone for up to 24 weeks), and then a follow-up period when children were returned to ART alone. The study is designed to evaluate three possible benefits of dual bNAb therapy in HIV-1-infected children: 1) to determine the duration of virologic control that can be maintained with dual bNAb treatment following early ART, providing proof-of-concept that bNAbs may serve as a possible alternative to standard ART in children with low viral reservoirs; 2) to investigate whether bNAb therapy is associated with changes in the size and/or the cellular or clonal composition of residual viral reservoirs, which will be highly informative for developing strategies to limit viral persistence and to destabilize viral reservoir homeostasis in pediatric patients; and 3) to evaluate whether treatment with bNAbs is associated with qualitative or quantitative changes in innate or adaptive antiviral immune responses, and if it facilitates the development of an antiviral immune profile that can enable spontaneous post-treatment viral control.


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 = $0 )
2026	2024	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	7	1/30/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	7	1/10/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $951,356 )
2024	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	7	4/30/2024	NON-COMPETING CONTINUATION	$95,071
2024	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	7	1/12/2024	NON-COMPETING CONTINUATION	$856,285
2024	2023	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	6	1/11/2024	EXTENSION WITH OR WITHOUT FUNDS	$408,015
2024	2022	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	5	1/11/2024	NON-COMPETING CONTINUATION	-$408,015
														Subtotal = $951,356

Issue Date FY: 2023 ( Subtotal = $993,747 )
2023	2023	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	6	2/8/2023	EXTENSION WITH OR WITHOUT FUNDS	$993,747
2023	2022	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	5	10/17/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $993,747

Issue Date FY: 2022 ( Subtotal = $1,395,641 )
2022	2022	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	5	3/11/2022	NON-COMPETING CONTINUATION	$0
2022	2022	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	5	1/24/2022	NON-COMPETING CONTINUATION	$1,395,641
														Subtotal = $1,395,641

Issue Date FY: 2021 ( Subtotal = $1,999,002 )
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	4	1/27/2021	NON-COMPETING CONTINUATION	$1,516,219
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	4	8/27/2021	NON-COMPETING CONTINUATION	$482,783
2021	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	3	11/20/2020	NON-COMPETING CONTINUATION	$0
2021	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	3	12/9/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,999,002

Issue Date FY: 2020 ( Subtotal = $1,848,151 )
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	3	1/31/2020	NON-COMPETING CONTINUATION	$1,484,707
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	3	8/24/2020	NON-COMPETING CONTINUATION	$363,444
														Subtotal = $1,848,151

Issue Date FY: 2019 ( Subtotal = $2,158,015 )
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	2	6/10/2019	NON-COMPETING CONTINUATION	$646,991
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	2	9/11/2019	NON-COMPETING CONTINUATION	$0
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	2	9/13/2019	NON-COMPETING CONTINUATION	$0
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	2	1/11/2019	NON-COMPETING CONTINUATION	$1,511,024
														Subtotal = $2,158,015

Issue Date FY: 2018 ( Subtotal = $1,077,403 )
2018	2018	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	1	3/13/2018	NEW	$0
2018	2018	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	1	2/19/2018	NEW	$1,077,403
														Subtotal = $1,077,403

Grand Total All Awards = $10,423,315

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A clinical trial to evaluate the impact of broadly neutralizing antibody VRC01 on HIV viral reservoir and maintenance of suppression in a cohort of early-treated children in Botswana

Award Number: U01AI135940

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: 02/20/2018

PERIOD OF PERFORMANCE END DATE: 01/31/2027

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