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A safety switch for an effective HIV-1 vaccine

Award Number: DP1DA043912
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2017
PERIOD OF PERFORMANCE END DATE: 02/28/2022

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A safety switch for an effective HIV-1 vaccine - PROJECT SUMMARY We have developed what appears to be an effective way to prevent HIV-1 infection despite high-dose intravenous challenges. This approach combines eCD4-Ig, an exceptionally broad and potent HIV-1 entry inhibitor with an adeno-associated virus (AAV) delivery system. After a one-time intramuscular inoculation with AAV-eCD4-Ig, rhesus macaques were protected for more than a year from multiple high-dose challenges with SHIV-AD8 and SIVmac239. This protection is likely to last for several additional years or more. A similar approach might also be taken using a cocktail of AAV-expressed broadly neutralizing antibodies (bNAbs), presuming that the problem of their greater immunogenicity can be addressed. In short, we are close to providing effective, long term protection for high-risk individuals such as intravenous drug users. However, there is one clear hurdle remaining. Specifically, while it is likely that eCD4-Ig and bNAbs are safe when passively administered, these proteins have never been expressed in many people for long periods of time, and there is no easy remedy for an adverse event. To that end, we are intensively exploring ways to suppress or stop entirely expression of an AAV transgene. We propose here to develop a number of small on- and off-switches that modulate transgene message-RNA stability, as well as kill-switches that permanently halt transgene expression. Our focus is on switches that are practical for in vivo use, always keeping our eye on the larger goal of making an effective HIV-1 prophylaxis strategy safe.


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: 2023 ( Subtotal = $0 )
2023	2021	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Drug Use and Addiction Research Programs	000	5	12/12/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $960,000 )
2021	2021	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Drug Use and Addiction Research Programs	000	5	2/26/2021	NON-COMPETING CONTINUATION	$960,000
														Subtotal = $960,000

Issue Date FY: 2020 ( Subtotal = $960,000 )
2020	2020	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Drug Use and Addiction Research Programs	000	4	2/25/2020	NON-COMPETING CONTINUATION	$960,000
														Subtotal = $960,000

Issue Date FY: 2019 ( Subtotal = $960,000 )
2019	2019	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Drug Use and Addiction Research Programs	000	3	2/27/2019	NON-COMPETING CONTINUATION	$960,000
														Subtotal = $960,000

Issue Date FY: 2018 ( Subtotal = $960,000 )
2018	2018	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Drug Use and Addiction Research Programs	001	2	4/26/2018	NON-COMPETING CONTINUATION	$96,000
2018	2018	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Drug Use and Addiction Research Programs	000	2	2/27/2018	NON-COMPETING CONTINUATION	$864,000
														Subtotal = $960,000

Issue Date FY: 2017 ( Subtotal = $960,000 )
2017	2017	SCRIPPS RESEARCH INSTITUTE, THE	130 SCRIPPS WAY	JUPITER	FL	33458	PALM BEACH	USA	Drug Use and Addiction Research Programs	000	1	3/24/2017	NEW	$960,000
														Subtotal = $960,000

Grand Total All Awards = $4,800,000

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A safety switch for an effective HIV-1 vaccine

Award Number: DP1DA043912

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2017

PERIOD OF PERFORMANCE END DATE: 02/28/2022

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