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MEPCS (Multi-epitope protease cleavage sites) vaccine for protecting against SIV rectal transmission

Award Number: R01AI181671
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2025
PERIOD OF PERFORMANCE END DATE: 06/30/2029

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MEPCS (Multi-epitope protease cleavage sites) vaccine for protecting against SIV rectal transmission - Summary Novel vaccine strategies is needed to develop a safe, effective, and broadly accessible HIV vaccine to end the HIV pandemic. This proposal is built upon several innovative advancements. First, learned from natural immunity observed in a group of HIV resistant Kenyan female sex workers, we found 12 protease cleavage sites (PCS) in HIV are critical for virus maturation due to their essential function in tightly controlled cleavage of Gag, Gag-Pol, and Nef precursor proteins. Sequences surrounding the HIV PCS are immunogenic and highly conserved across global HIV subtypes, thereby a vaccine based on 12 PCS immunogens will be globally accessible and likely to prevent virus escape mutations. Further, our recent studies demonstrated that a PCS vaccine delivered by recombinant vesicular stomatitis virus (rVSV) vector and nanoformulation protected more than 80% of vaccinated female Mauritian cynomolgus macaques (MCMs) against SIVmac251 intravaginal challenges, which is associated with vaccine elicited potent PCS-specific CD8 T cell responses. However, in previous studies, 12 PCS immunogens were individually expressed in the rVSV. To improve vaccine immunogen presentation and facilitate the vaccine preparation, 12 PCS immunogens should be expressed in a single cassette, i.e., multi-epitope PCS (MEPCS). i.e., multi-epitope PCS (MEPCS). To that end, we have developed a cold-chain friendly and long-term stable MEPCS-mRNA-LNP vaccine. We found that SIV MEPCS-mRNA-LNP vaccine induced a potent PCS-specific CD8 T-cell immunity without inducing generalized inflammation and CD4 T-cell activation. Based on our strong preliminary date, we hypothesize that MEPCS vaccines would protect rhesus macaques against SIVmac251 rectal transmission. The reason we will use a rhesus macaque (RM)-SIV rectal challenge model is that the effectiveness of MEPCS vaccine needs to be validated in the most rigorous rhesus macaques and anal sex is the most common HIV transmission in the United States of America. The primary objective of this study is to evaluate the effectiveness of cold- chain friendly and long-term stable MEPCS-mRNA-LNP vaccine in comparison with rVSV-MEPCS vaccines in protecting RMs against SIVmac251 intrarectal challenge and to better understand the immune correlated protection. in this proposed study we will comparatively evaluate the effectiveness of MEPCS-mRNA-LNP with rVSV-MEPCS vaccines against SIVmac251 intrarectal challenge in RMs. The proposed study has the great potential to develop a new HIV/SIV vaccine to prevent HIV/SIV rectal transmission. The novel MEPCS immunogens plus the cold-chain friendly and long-term stable mRNA- LNP formulation makes this proposed study highly innovative and significant. .


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	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	2200 VINE ST # 830861	LINCOLN	NE	68503	LANCASTER	USA	Allergy and Infectious Diseases Research	000	1	3/31/2026	NEW	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $657,563 )
2025	2025	THE WISTAR INSTITUTE OF ANATOMY AND BIOLOGY	3601 SPRUCE ST	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Allergy and Infectious Diseases Research	000	2	9/2/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$657,563
2025	2024	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	2200 VINE ST # 830861	LINCOLN	NE	68503	LANCASTER	USA	Allergy and Infectious Diseases Research	001	1	9/3/2025	NEW	$0
														Subtotal = $657,563

Issue Date FY: 2024 ( Subtotal = $650,156 )
2024	2024	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	2200 VINE ST # 830861	LINCOLN	NE	68503	LANCASTER	USA	Allergy and Infectious Diseases Research	000	1	8/21/2024	NEW	$650,156
														Subtotal = $650,156

Grand Total All Awards = $1,307,719

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MEPCS (Multi-epitope protease cleavage sites) vaccine for protecting against SIV rectal transmission

Award Number: R01AI181671

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2025

PERIOD OF PERFORMANCE END DATE: 06/30/2029

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