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Optimization of a DNA Subunit Regimen for an HIV Vaccine

Award Number: R44AI102702
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: 07/01/2012
PERIOD OF PERFORMANCE END DATE: 04/30/2017

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Optimization of a DNA Subunit Regimen for an HIV 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(BaL) genetically linked via a 20 amino acid linker to the D1D2 domains of human CD4. Rhesus macaques were inoculated with rhFLSC, a surrogate version of FLSC that contains CD4 derived from rhesus macaques. The rhFLSC provided significant protection against rectal challenge with multiple, low doses of R5 tropic, and heterologous SHIV162P3. These observations propelled FLSC into preclinical development and evaluation in a phase 1 clinical trial (supported by BMGF, MHRP, NIAID). Consistent with the observations made in the RV144 clinical trial, the protection we observed waned as the antibody titers dropped. The presence of significant populations of single function T cells (secreting IFN-¿ or IL-2) also appeared to inversely correlate with the protection generated by rhFLSC subunit. Our collaborators found that the simultaneous coadministration of pDNA and protein dramatically heightens the potency and extends the lifespan of the antibody response. Vaccination with pDNA expressing antigen and IL-12 administered by electroporation in macaques induces multifunctional T cells that are known to correlate with protection that could also improve the efficacy provided by FLSC subunit. Our goal here is to build upon these observations and determine if a pDNA/subunit combination vaccine can enhance the quality and durability of the immune response necessary to provide >70% efficacy after 1 year post vaccination. Our phase 1 objective is to rank order FLSC DNA/subunit immunization regimens based on the quality and durability of the immune response in mice. Using the top regimens defined in Phase I, we will determine if the selected vaccination regimen provides protection from SHIV challenge that is superior to that observed in RV144 and remains effective out to at least one year post vaccination through the following phase II specific aims: 1. Rank order FLSC DNA/subunit immunization regimens based on the quality and durability of the immune response in macaques. 2. Rank order FLSC DNA/subunit immunization regimens based on their efficacy against SHIV162P3 challenge. By the end of this project, we should identify a regimen that extends the longevity of humoral and cellular responses to provide >70% efficacy upon heterologous SHIV162P3 challenge after 1 year. Should this optimized delivery regimen fulfill the phase II goals, it will be fast-tracked into human clinical 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 = $0 )
2019	2015	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	4	6/24/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2015	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	4	8/25/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $549,209 )
2015	2015	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	4	4/15/2015	NON-COMPETING CONTINUATION	$999,999
2015	2015	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	4	5/11/2015	NON-COMPETING CONTINUATION	-$450,790
														Subtotal = $549,209

Issue Date FY: 2014 ( Subtotal = $1,450,791 )
2014	2014	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	3	4/18/2014	NON-COMPETING CONTINUATION	$999,999
2014	2014	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	2	3/19/2014	SUPPLEMENT FOR EXPANSION	$450,792
														Subtotal = $1,450,791

Issue Date FY: 2013 ( Subtotal = $700,194 )
2013	2013	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	2	5/3/2013	EXTENSION WITH OR WITHOUT FUNDS	$700,194
2013	2012	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	1	5/2/2013	NEW	$0
														Subtotal = $700,194

Issue Date FY: 2012 ( Subtotal = $224,027 )
2012	2012	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	1	5/30/2012	NEW	$224,027
														Subtotal = $224,027

Grand Total All Awards = $2,924,221

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Optimization of a DNA Subunit Regimen for an HIV Vaccine

Award Number: R44AI102702

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: 07/01/2012

PERIOD OF PERFORMANCE END DATE: 04/30/2017

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