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Optimization of a Therapeutic HIVSIV Multi-Antigen DNA Vaccine

Award Number: R44AI110315
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: 07/01/2014
PERIOD OF PERFORMANCE END DATE: 07/31/2018

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Optimization of a Therapeutic HIVSIV Multi-Antigen DNA Vaccine - DESCRIPTION: The HIV pandemic is one of the greatest public health challenges in history. It is estimated that 33 million people are living with HIV and 2.7 million of those are newly infected In a number of developed countries, the risk of death associated with HIV-1 infection has sharply declined due to the use of highly active antiretroviral therapy (HAART). Unfortunately, the rate of new HIV infections remains undiminished, even with the ever increasing availability of prevention programs and HAART. For these reasons, a vaccine that could prevent or control the spread of HIV is urgently needed. A recent study showed that a skin-delivered therapeutic DNA vaccine co-formulated with a novel adjuvant stimulated mucosal T cell responses in SIV-infected macaques and led to durable viral suppression in a subset of animals after stopping ART. These results are in striking contrast to previous therapeutic vaccines employing intramuscular delivery of DNA that failed to induce an effect or at best, induced a 1-2 log reduction in viremia or transient control of viral rebound. We propose to make therapeutic DNA vaccination even more effective by 1) using a more potent combination of drugs (cART) to maximize the effects of the vaccine, 2) using a more potent adjuvant strategy that increases DNA vaccine induction of antibody and T cell responses and stimulates homing of these responses to gut associated lymphoid tissues, and 3) using a novel electroporation DNA delivery device that more efficiently delivers DNA into the skin (a more immunocompetent site than muscle for induction of systemic and mucosal responses). Our overarching hypothesis is that a vaccine-induced functional cure will be mediated by strong mucosal responses, and that increasing and focusing these responses to the gut in maximally suppressed infections via use of an optimized mucosal adjuvant and delivery into skin will maximally reduce or prevent residual viruses from emerging from the gut reservoir after stopping cART. To this end, we have assembled a panel of four DNA-based adjuvants that we hypothesize will induce robust anti-HIV mucosal and systemic immune responses when combined. Under this fast track SBIR, we will investigate adjuvant combinations with our HIV/SIV multi-antigen (MAG) DNA vaccine consisting of plasmids expressing env (gp160), a gag/pol fusion, and a nef/tat/vif fusion. We anticipate that an optimal combination of these adjuvants will elevate the performance of our MAG DNA vaccine to a level worthy of human trials.


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: 2019 ( Subtotal = -$10,017 )
2019	2017	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	4	1/9/2019	NON-COMPETING CONTINUATION	-$10,017
														Subtotal = -$10,017

Issue Date FY: 2017 ( Subtotal = $838,478 )
2017	2017	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	4	7/13/2017	NON-COMPETING CONTINUATION	$838,478
														Subtotal = $838,478

Issue Date FY: 2016 ( Subtotal = $968,957 )
2016	2016	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	3	7/21/2016	NON-COMPETING CONTINUATION	$968,957
														Subtotal = $968,957

Issue Date FY: 2015 ( Subtotal = $998,486 )
2015	2015	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	2	8/21/2015	EXTENSION WITH OR WITHOUT FUNDS	$998,486
														Subtotal = $998,486

Issue Date FY: 2014 ( Subtotal = $300,000 )
2014	2014	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	1	6/20/2014	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $3,095,904

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Optimization of a Therapeutic HIVSIV Multi-Antigen DNA Vaccine

Award Number: R44AI110315

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: 07/01/2014

PERIOD OF PERFORMANCE END DATE: 07/31/2018

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