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Vectored delivery of anti-HIV antibodies for mucosal protection

Award Number: R01AI176522
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: 03/14/2023
PERIOD OF PERFORMANCE END DATE: 02/28/2027

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Vectored delivery of anti-HIV antibodies for mucosal protection - Project Summary/Abstract The poor immunogenicity of the HIV envelope spike and its vast variability represent major obstacles for efficient elicitation of protective anti-HIV antibodies. One promising strategy is to bypass the immune system and deliver already known and well-characterized potent and broadly neutralizing antibodies directly to the host. However, periodic administrations of large amounts of protein would be required for long-term effects. Recombinant adeno- associated virus (AAV) vectors have been widely used for gene delivery applications because of their safety and cost-efficiency: one single injection can account for long term expression of the transgene. The use of AAV vectors would bypass the need for periodic administrations of antibody and, as long as the delivered protein is viewed as self, it can result in continuous durable expression. Studies in monkeys and in mice have already shown the extreme promise of AAV for this antibody delivery approach against HIV, and pioneer human trials have demonstrated its safety and feasibility. However, only antibodies in IgG form (monomeric immunoglobulin) have been employed in such AAV-antibody delivery applications, while polymeric immunoglobulins (such as dimeric IgA and pentameric IgM) have been overlooked, despite their desirable characteristics for mucosal protection. In addition, little is known about what proportion of circulating AAV-delivered antibody gets transferred to relevant viral entry points such as the rectal or vaginal mucosae and how that correlates with the level of protection against mucosal exposure that can be achieved. Building up on our previous monkey trials, what we propose here is to evaluate AAV-mediated delivery of a potent and broadly neutralizing antibody as different immunoglobulin types and assess the degree of protection that can be achieved to mucosal viral challenge by each type (Aim 1). We will use the highly relevant macaque model and quantitate in vivo AAV-produced antibody in circulation and in the relevant mucosae. Our goal is to find what immunoglobulin type shows optimal transfer of the AAV-delivered antibody to the viral point of entry in mucosae and/or optimal protection against challenge. Because HIV is mainly transmitted sexually, our findings will be highly relevant in the fight against HIV transmission. Our overall goal is to inform and guide development of the AAV-antibody concept for its use in people.


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: 2025 ( Subtotal = $1 )
2025	2025	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Allergy and Infectious Diseases Research	000	3	3/27/2025	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2024 ( Subtotal = $762,712 )
2024	2024	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Allergy and Infectious Diseases Research	001	2	5/23/2024	NON-COMPETING CONTINUATION	$76,272
2024	2024	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Allergy and Infectious Diseases Research	000	2	2/7/2024	NON-COMPETING CONTINUATION	$686,440
														Subtotal = $762,712

Issue Date FY: 2023 ( Subtotal = $785,297 )
2023	2023	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Allergy and Infectious Diseases Research	000	1	3/14/2023	NEW	$785,297
2023	2023	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	Allergy and Infectious Diseases Research	001	1	3/24/2023	NEW	$0
														Subtotal = $785,297

Grand Total All Awards = $1,548,010

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Vectored delivery of anti-HIV antibodies for mucosal protection

Award Number: R01AI176522

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: 03/14/2023

PERIOD OF PERFORMANCE END DATE: 02/28/2027

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