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Targeting HIV reservoirs in children with HIVIS DNA and MVA-CMDR vaccines

Award Number: U01AI135941
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: 02/01/2018
PERIOD OF PERFORMANCE END DATE: 02/28/2025

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Targeting HIV reservoirs in children with HIVIS DNA and MVA-CMDR vaccines - This will be the first pediatric study with prime-boost HIVIS DNA and MVA-CMDR therapeutic vaccines. Our goal is to develop therapeutic HIV vaccines to reduce the HIV reservoirs in children and youth with HIV. Our scientific premise is that the prime-boost HIVIS DNA and MVA-CMDR vaccines induce cellular and humeral immune responses important for clearing infected cells. They were selected for children based on ample adult safety data. Early treated children are an ideal population to investigate therapeutic HIV vaccines because of their healthy immunity and small HIV reservoirs. We will explore a novel strategy of giving a licensed vaccine against human papilloma virus that contains toll-like receptor (TLR) 4 agonist adjuvant to boost immune responses to HIVIS DNA. Participants will be children from South Africa. The project was conceptualized under the EPIICAL Consortium and will be conducted in collaboration with the U.S Military HIV Research Program. EPIICAL does not provide any funding for this study but provides a platform for sharing expertise, data and samples from cohorts that will propel the development of therapeutic vaccine strategies for children forward. A maximum of twenty-five participants will be enrolled in this 72-week study. Participants will be 9 to 25 years old, have started HIV medications prior to 6 months of age and are virally suppressed. They will be randomly assigned to HIV vaccines (n=10) vs. HIV vaccines+ TLR4 agonist (n=10) vs. control (no interventions) (n=5). Vaccines will be given at weeks O and 4 for HIVIS DNA, weeks 0, 4 and 24 for TLR4 agonist, and weeks 24 and 36 for MVA-CMDR. We will extensively measure the changes of HIV reservoirs and immune responses post interventions. Aim 1: To quantitate and characterize the HIV reservoirs before and after HIVIS DNA ± TLR4 agonist and MVA-CMDR vaccination Aim 2: To characterize HIV-specific cellular and humeral immune responses before and after vaccination and assess their relationship to the HIV reservoir endpoints. The knowledge generated will contribute to the optimization of therapeutic HIV vaccine strategies and exert sustained influence on HIV cure research for children and youth.


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: 2024 ( Subtotal = $983,724 )
2024	2024	THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC.	6720A ROCKLEDGE DR	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	005	7	8/14/2024	NON-COMPETING CONTINUATION	$0
2024	2024	THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC.	6720A ROCKLEDGE DR	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	7	3/26/2024	NON-COMPETING CONTINUATION	$898,170
2024	2024	THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC.	6720A ROCKLEDGE DR	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	7	5/17/2024	NON-COMPETING CONTINUATION	$85,554
2024	2023	THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC.	6720A ROCKLEDGE DR	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	004	6	6/18/2024	EXTENSION WITH OR WITHOUT FUNDS	$1,034,910
2024	2022	THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC.	6720A ROCKLEDGE DR	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	003	5	6/18/2024	NON-COMPETING CONTINUATION	-$762,210
2024	2021	THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC.	6720A ROCKLEDGE DR	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	002	4	6/18/2024	NON-COMPETING CONTINUATION	-$272,700
														Subtotal = $983,724

Issue Date FY: 2023 ( Subtotal = $1,518,958 )
2023	2023	THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC.	6720A ROCKLEDGE DR	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	6	3/3/2023	EXTENSION WITH OR WITHOUT FUNDS	$1,518,958
														Subtotal = $1,518,958

Issue Date FY: 2022 ( Subtotal = $762,210 )
2022	2022	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	002	5	7/22/2022	NON-COMPETING CONTINUATION	$377,131
2022	2022	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	5	2/2/2022	NON-COMPETING CONTINUATION	$385,079
2022	2021	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	4	12/16/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $762,210

Issue Date FY: 2021 ( Subtotal = $986,671 )
2021	2021	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	004	4	6/2/2021	NON-COMPETING CONTINUATION	$0
2021	2021	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	4	2/4/2021	NON-COMPETING CONTINUATION	$635,937
2021	2021	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	002	4	4/29/2021	NON-COMPETING CONTINUATION	$0
2021	2021	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	003	4	5/26/2021	NON-COMPETING CONTINUATION	$263,108
2021	2021	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	4	4/20/2021	NON-COMPETING CONTINUATION	$87,626
														Subtotal = $986,671

Issue Date FY: 2020 ( Subtotal = $776,214 )
2020	2020	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	3	1/24/2020	NON-COMPETING CONTINUATION	$649,602
2020	2020	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	3	8/28/2020	NON-COMPETING CONTINUATION	$126,612
2020	2020	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	002	3	9/1/2020	NON-COMPETING CONTINUATION	$0
2020	2020	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	003	3	9/17/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $776,214

Issue Date FY: 2019 ( Subtotal = $680,090 )
2019	2019	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	2	1/30/2019	NON-COMPETING CONTINUATION	$680,090
2019	2019	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	2	8/8/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $680,090

Issue Date FY: 2018 ( Subtotal = $724,299 )
2018	2018	HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC., THE	6720-A ROCKLEDGE DR STE 100	BETHESDA	MD	20817	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	2/1/2018	NEW	$724,299
														Subtotal = $724,299

Grand Total All Awards = $6,432,166

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Targeting HIV reservoirs in children with HIVIS DNA and MVA-CMDR vaccines

Award Number: U01AI135941

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: 02/01/2018

PERIOD OF PERFORMANCE END DATE: 02/28/2025

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