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Phase 1a/1b Clinical Trials of Multivalent Opioid Vaccine Components

Award Number: UH3DA047711
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2018
PERIOD OF PERFORMANCE END DATE: 03/31/2028

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Phase 1a/1b Clinical Trials of Multivalent Opioid Vaccine Components - Project Summary Currently, abuse of prescription opioid analgesics and heroin is a pervasive problem in the U.S. Although several medications, including methadone, buprenorphine, and naltrexone, are available and effective in treating opioid use disorder (OUD), long-term relapse rates remain high. The current studies are designed to examine a novel approach to treating OUD, namely use of a vaccine (OXY-KLH) targeted against oxycodone, one of the most commonly abused prescription opioids, and a vaccine (M-KLH) targeted against heroin/morphine. Ultimately, a bivalent vaccine (OXY-KLH and M-KLH) will be developed that will target oxycodone and heroin. The long-term goal of this research is to develop a multivalent vaccine directed against oxycodone, heroin, and other relevant opioids. However, during our pre-IND meeting, the FDA/CBER asked that we study each vaccine separately before moving forward with development of the bivalent vaccine. The current application proposes a Phase 1a/1b study designed to evaluate the safety (Aim 1), immunogenicity (Aim 2), and preliminary efficacy (Aim 3) of OXY-KLH during the UG3 phase of the grant period (Study 1) and a similar Phase 1a/1b study of M-KLH during the UH3 phase of the grant period (Study 2). Transition to the UH3 phase will be determined after safety, immunogenicity, and preliminary efficacy analyses have been performed for the OXY-KLH vaccine. Overall, the proposed studies will provide a great deal of information about the safety and potential efficacy of the vaccines in reducing the abuse liability of opioids, which will be administered in a controlled laboratory setting. If the outcomes of the proposed studies with OXY-KLH and M- KLH are favorable, we will proceed with development of the bivalent vaccine (OXY-KLH plus M-KLH).


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 = $3,705,613 )
2026	2026	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	002	4	4/30/2026	NON-COMPETING CONTINUATION	$0
2026	2026	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	001	4	4/1/2026	NON-COMPETING CONTINUATION	$3,705,613
2026	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	000	3	2/19/2026	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $3,705,613

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	000	3	4/17/2025	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $292,736 )
2024	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	000	3	4/5/2024	EXTENSION WITH OR WITHOUT FUNDS	$292,736
2024	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	001	3	4/8/2024	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $292,736

Issue Date FY: 2023 ( Subtotal = $3,569,552 )
2023	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	003	3	7/31/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
2023	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	002	3	7/20/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
2023	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	000	3	3/31/2023	EXTENSION WITH OR WITHOUT FUNDS	$3,569,552
2023	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	001	3	5/25/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
2023	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	004	3	8/4/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $3,569,552

Grand Total All Awards = $7,567,901

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Phase 1a/1b Clinical Trials of Multivalent Opioid Vaccine Components

Award Number: UH3DA047711

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/15/2018

PERIOD OF PERFORMANCE END DATE: 03/31/2028

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