Tuesday, June 17, 2025 6/17/2025

An HIV Vaccine Strategy Based on Priming with rVSV Expressing FLSC

Award Number: R44AI114319
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: 08/12/2014
PERIOD OF PERFORMANCE END DATE: 07/31/2018

Group Awards By:

View Award Description

An HIV Vaccine Strategy Based on Priming with rVSV Expressing FLSC - DESCRIPTION: Based on the prevailing evidence, we believe that a highly effective vaccine for HIV prophylaxis must induce long-lasting, broadly cross-reactive antibody responses to envelope that exhibit antiviral activity, as well as multi-antigen, polyfunctional CD4+ and CD8+ T cell responses that produce antiviral chemokines and cytokines and are possibly biased towards an effector memory phenotype. Our strategy utilizes a novel immunogen, Full Length Single Chain (FLSC), to present conserved epitopes that exist on the HIV envelope spike, including ones that may form within the quaternary structure of the envelope. The constrained structure, which is achieved with single chain complexes of gp120 and CD4 fragments, stabilizes and presents conserved domains including, but not limited to, "CD4-induced" (CD4i) epitopes. We have shown that FLSC induces cross-reactive antibodies and protective immune responses in macaques. To reach our goal of developing and clinically evaluating a novel prophylactic HIV vaccine strategy with the ability to induce concurrent durable and protective antibody and CMI responses, we will exploit the collective developments in recombinant vesicular stomatitis virus (rVSV) vectors and subunit vaccine designs accrued at Profectus in an extensive series of pre-clinical and clinical trials, along with other key technical observations made by our academic collaborators. We believe one possible way to achieve this is to combine virus-based vectors expressing FLSC and subunit forms of FLSC using optimal prime-boost regimens. Based on preliminary data using prototypic rVSV vectors, our central hypothesis is that it will be possible to generate constrained SIV/HIV immunogens that contain rhesus or human FLSC anchored in cell/viral membranes through linkage the VSV G stem allowing for exposure of conserved epitopes. In Phase 1, we will generate rVSVs expressing Gstem linked rhesus and human FLSCs in the attenuated rVSVN4CT1 backbone, which has recently demonstrated safety and immunogenicity in human trials (Aim 1). The immunogenicity of these vectors will be initially confirmed in a mouse study (Aim 2). In Phase 2, we will evaluate the stability of the rVSV genomes (Aim 3), which will then be used to further determine the rank order of optimal prime/boost regimens of rVSV and protein subunit FLSC vaccines in macaques by assessment of immune responsiveness (Aim 4) and efficacy (Aim 5) in a heterologous SIVmac251 challenge model. Successful achievement of our goals will produce novel antigens and an optimal prime-boost regimen for further study of protective HIV vaccines.


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 = -$2 )
2019	2016	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	3	1/11/2019	NON-COMPETING CONTINUATION	-$2
														Subtotal = -$2

Issue Date FY: 2016 ( Subtotal = $1,000,000 )
2016	2016	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	3	7/14/2016	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2015 ( Subtotal = $1,000,000 )
2015	2015	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	2	7/22/2015	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

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	8/11/2014	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $2,299,998

Top

All Categories

About

Search

Reports

Data Submission

Award Information

An HIV Vaccine Strategy Based on Priming with rVSV Expressing FLSC

Award Number: R44AI114319

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: 08/12/2014

PERIOD OF PERFORMANCE END DATE: 07/31/2018

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer