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rVSV Vectored Vaccine to Protect Against Ebola and Marburg Viruses

Award Number: R01AI098817
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: 05/01/2012
PERIOD OF PERFORMANCE END DATE: 04/30/2019

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rVSV Vectored Vaccine to Protect Against Ebola and Marburg Viruses - DESCRIPTION (provided by applicant): Ebola virus (EboV) and Marburg virus (MarV) are filamentous enveloped non-segmented negative sense RNA viruses representing the two genera that comprise the family Filoviridae. These viruses are important human pathogens with case fatality rates ranging from 55% to 90% for EboV and up to 90% for MarV. These agents are classified as Category A Priority Pathogens by the NIAID/NIH and CDC, and there are presently no approved active or passive interventions for exposure resulting from natural outbreak, laboratory accident, or deliberate misuse. Public health concern is based on both the emerging infectious disease status of these viruses and their potential use as biologic weapons. An effective prophylactic vaccine would find application with medical personnel and close contacts during outbreaks in endemic areas of sub-Saharan Africa, with laboratory workers engaged in filovirus research, and with military and civilian personnel threatened by weaponized filoviruses. The ideal vaccine to meet both the outbreak and bio-weapon scenarios would rapidly confer protection against all species of EboV and MarV with a single administration. Among the vaccine technologies investigated to date, a tri-valent filovirus vaccine vectored by recombinant vesicular stomatitis virus (rVSV) has shown the greatest potential as a single administration vaccine with the capacity to rapidly provide broad protection against EboV and MarV. Profectus BioSciences has developed a replication competent attenuated rVSV vaccine delivery platform (rVSVN4CT1) that: 1) retains the immunogenicity of vaccines based on the non-attenuated vector, 2) has been manufactured under cGMPs at commercial scale, and 3) has been judged by the FDA to be safe for human testing. Thus, this application proposes: 1) to confirm that an attenuated tri-valent rVSVN4CT1 vectored filovirus vaccine will protect monkeys against challenge with EboV and MarV, 2) compliantly prepare seed stocks of the three viruses in the vaccine under conditions that will support future manufacture under cGMPs, 3) use the compliant seed stocks to prepare tri-valent vaccine that will be tested in a GLP neuro-toxicology study in non-human primates to confirm safety, 4) use the compliant tri-valent vaccine in development studies to identify a lyophilized formulation with the stability characteristics required for practical field use, and 5) test the lyophilized tri-valent vaccine to confirm that it protects NHPs from EboV and MarV when administered pre-exposure and post-exposure.


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 = $0 )
2020	2016	PROFECTUS BIOSCIENCES, INC.	401 N MIDDLETOWN RD # 205	PEARL RIVER	NY	10965	ROCKLAND	USA	Allergy and Infectious Diseases Research	000	5	11/5/2019	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2016	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	5	5/7/2018	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	001	5	8/25/2017	EXTENSION WITH OR WITHOUT FUNDS	$472,566
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	-$472,566
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $1,208,817 )
2016	2016	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	5	4/25/2016	EXTENSION WITH OR WITHOUT FUNDS	$1,208,817
														Subtotal = $1,208,817

Issue Date FY: 2015 ( Subtotal = $947,203 )
2015	2015	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	4	4/23/2015	NON-COMPETING CONTINUATION	$947,203
														Subtotal = $947,203

Issue Date FY: 2014 ( Subtotal = $937,397 )
2014	2014	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	3	4/11/2014	NON-COMPETING CONTINUATION	$937,397
														Subtotal = $937,397

Issue Date FY: 2013 ( Subtotal = $1,122,164 )
2013	2013	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	2	4/17/2013	NON-COMPETING CONTINUATION	$1,074,414
2013	2013	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	2	5/31/2013	NON-COMPETING CONTINUATION	$47,750
														Subtotal = $1,122,164

Issue Date FY: 2012 ( Subtotal = $1,120,171 )
2012	2012	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	1	5/1/2012	NEW	$1,120,171
														Subtotal = $1,120,171

Grand Total All Awards = $5,335,752

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rVSV Vectored Vaccine to Protect Against Ebola and Marburg Viruses

Award Number: R01AI098817

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: 05/01/2012

PERIOD OF PERFORMANCE END DATE: 04/30/2019

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