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Pushing HIV-1 Vaccine Protection to the Mucosal Barrier

Award Number: R56AI184121
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: 07/19/2024
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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Pushing HIV-1 Vaccine Protection to the Mucosal Barrier - Abstract Most gene-based vaccines are replication-defective mRNA, DNA, or adenovirus (Ad) vaccines. In each case, the vaccine delivers its one copy of an antigen gene and expresses 1X of the antigens that are encoded by the vaccine. We developed single cycle Ad (SC-Ad) vaccines that replicate vaccine antigen genes up to 10,000-fold in every cell to amplify antigen production but do not produce infectious progeny viruses. When RD-Ad and SC- Ad6 expressing HIV-1 antigens or SARS-CoV-2 spike are compared, SC-Ad produces 100 times more antigen than RD-Ad and generates significantly higher antibodies than RD-Ad-Spike or mRNA vaccines. When spike- immunized animals were challenged 10.5 months after single immunization, SC-Ad reduced SARS-CoV-2 lung viral loads and damage and preserved body weights better than RD-Ad. During the COVID-19 pandemic, we tested SC-Ads expressing SIV gag and clade C HIV-1 Env in rhesus macaques by intramuscular (IM), intranasal (IN), and intravaginal (IVAG) routes of immunization in combination with IM co-immunization with adjuvanted clade C SOSIP protein. When the macaques were challenged vaginally with clade C SHIV.CH505.375H.dCT 1.5 years after last vaccine, PBS, IN, and IM vaccinated animals became infected with similar kinetics with only one IN animal resisting infection. In contrast, 50% of the IVAG macaques resisted vaginal challenge. These data suggest there are great merits to creating a mucosal barrier against incoming SHIV at the site of viral entry. Given this, this project will determine the reproducibility of this protection and examine how vaginal immunization drives local-regional immune responses in the female reproductive tract (FRT) and if these responses might be amplified by co-immunization in this site. Proof of concept here for being able to “push” immune responses into the FRT in macaques will allow these approaches to be translated for humans, to protect not just women, but all sexes and gender identities from vaginal, rectal, or penile exposures to HIV-1.


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: 2027 ( Subtotal = -$13,643 )
2027	2024	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Allergy and Infectious Diseases Research	000	1	10/21/2026	NEW	-$13,643
														Subtotal = -$13,643

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Allergy and Infectious Diseases Research	000	1	9/15/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $745,752 )
2024	2024	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Allergy and Infectious Diseases Research	000	1	7/19/2024	NEW	$745,752
														Subtotal = $745,752

Grand Total All Awards = $732,109

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Pushing HIV-1 Vaccine Protection to the Mucosal Barrier

Award Number: R56AI184121

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: 07/19/2024

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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