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Novel Mucosal Adjuvant for an HIV DNA Vaccine

Award Number: R44AI089290
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: 04/01/2010
PERIOD OF PERFORMANCE END DATE: 06/30/2019

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Novel Mucosal Adjuvant for an HIV DNA Vaccine - DESCRIPTION (provided by applicant): Our primary approach to develop an effective prophylactic vaccine against HIV utilizes a novel immunogen called the Full Length Single Chain (FLSC) that consists of gp120 derived from HIV-1 genetically linked via a 20 amino acid linker to the D1D2 domains of human CD4. When rhesus macaques were inoculated with versions of FLSC that contain CD4 derived from rhesus macaques and either HIV gp120 or SIV gp130, significant protection against rectal challenge with multiple, low doses of either an R5 tropic, heterologous SHIV162P3, or heterologous SIVmac251 was observed. These observations propelled FLSC into preclinical development and evaluation in a phase 1 clinical trial (supported by BMGF, MHRP, NIAID). Further, vaccination with DNA expressing FLSC and IL-12 administered by electroporation in macaques induces multifunctional T cells that are known to correlate with protection and improved efficacy. In our most recent macaque study, a FLSC DNA prime / protein boost regimen yielded 75% efficacy against a cross clade challenge. In collaboration with others, we have also developed a DNA / protein co-delivery regimen that evokes higher-titered, longer-lived anti-FLSC responses. However, we believe that our approach can be dramatically improved by targeting these anti-FLSC responses to mucosal sites where HIV enters the host and establishes infections. To improve mucosal immune responses we sought to develop a mucosal homing DNA adjuvant that targets lymphocytes to mucosal immune effector sites after systemic vaccination. In preliminary studies, we identified two putative mucosal homing DNA adjuvants. Under phase I, we demonstrated that one of these putative adjuvants does indeed induce the homing of lymphocytes to mucosal immune effector sites after systemic i.m. immunization. Under phase II, we intend to expand upon these observations and demonstrate that this adjuvant targets vaccine-specific immune responses to mucosal sites in primates.


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: 2020 ( Subtotal = -$104 )
2020	2017	PROFECTUS BIOSCIENCES, INC.	401 N MIDDLETOWN RD # 205	PEARL RIVER	NY	10965	ROCKLAND	USA	Allergy and Infectious Diseases Research	000	3	12/9/2019	NON-COMPETING CONTINUATION	-$104
														Subtotal = -$104

Issue Date FY: 2017 ( Subtotal = $793,348 )
2017	2017	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	001	3	7/21/2017	NON-COMPETING CONTINUATION	$59,716
2017	2017	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	3	6/1/2017	NON-COMPETING CONTINUATION	$733,632
														Subtotal = $793,348

Issue Date FY: 2016 ( Subtotal = $733,632 )
2016	2016	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	2	6/29/2016	COMPETING CONTINUATION	$733,632
														Subtotal = $733,632

Grand Total All Awards = $1,526,876

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Novel Mucosal Adjuvant for an HIV DNA Vaccine

Award Number: R44AI089290

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: 04/01/2010

PERIOD OF PERFORMANCE END DATE: 06/30/2019

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