Wednesday, June 18, 2025 6/18/2025

Development of sG as a human vaccine against Nipah/Hendra

Award Number: R01AI098760
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: 12/31/2018

Group Awards By:

View Award Description

Development of sG as a human vaccine against Nipah/Hendra - DESCRIPTION (provided by applicant): Nipah virus (NiV) and Hendra virus (HeV) are closely related viral zoonoses that form the genus Henipavirus in the family Paramyxoviridae. They are enveloped, negative-sense RNA viruses that cause a systemic and fatal disease in a variety of animal hosts and in humans. In some outbreaks, the death toll has reached as high as 75%. They are classified as biological safety level-4 (BSL4) viruses and possess several characteristics that justify their listing as Category C biothreat agents by the NIH and CDC including the ability to be transmitted via aerosol. There is currently no approved vaccine or therapeutic against either NiV or HeV. Annual outbreaks of NiV human infections in Bangladesh and other areas justify the benefit of a prophylactic vaccine for improving public health as well as reducing their potential as a biothreat. Immunization and challenge studies performed in cats, ferrets, and nonhuman primates using recombinant HeV soluble attachment protein G, HeV-sG, have demonstrated that a HeV-sG subunit vaccine can be completely effective against both HeV and NiV. In fact, HeV-sG subunit is currently being evaluated in Australia as an equine vaccine. Our objective here is to produce 1 gram of HeV-sG that will be suitable to perform IND-supportive toxicology and efficacy studies as necessary steps to support the evaluation of HeV-sG as a human vaccine against NiV and HeV. We will do so through the following specific aims: 1) Optimize HeV-sG immunogen/adjuvant formulation; 2) Identify release assays for HeV-sG; 3) Manufacture 1 g of HeV-sG; 4) Perform IND supportive animal studies. By the end of the funding period, we will have (i) identified an adjuvant suitable for further clinical development; ii) prepared a characterized research-grade "pre-seed" for use to manufacture a HeV-sG Master Cell Bank; (iii) optimized a development-scale process suitable for the manufacturing of cGMP clinical trial materials under future proposals; (iv) manufactured at least 1 g of development-grade vaccine to perform IND supportive toxicology and efficacy studies, and (v) executed said animal studies. Subsequent applications will pursue cGMP manufacture of 1) a master cell bank and 2) clinical lots of HeV-sG vaccine for Phase 1 clinical evaluation.


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 = -$79,093 )
2019	2016	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	001	5	5/21/2019	EXTENSION WITH OR WITHOUT FUNDS	$1
2019	2016	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	5	5/21/2019	EXTENSION WITH OR WITHOUT FUNDS	-$79,094
														Subtotal = -$79,093

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	2/5/2018	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	8/26/2017	EXTENSION WITH OR WITHOUT FUNDS	$904,394
2017	2015	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	4	8/26/2017	NON-COMPETING CONTINUATION	-$904,394
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $1,129,038 )
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	$1,129,038
														Subtotal = $1,129,038

Issue Date FY: 2015 ( Subtotal = $1,035,051 )
2015	2015	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	4	4/16/2015	NON-COMPETING CONTINUATION	$1,035,051
														Subtotal = $1,035,051

Issue Date FY: 2014 ( Subtotal = $970,588 )
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	$970,588
														Subtotal = $970,588

Issue Date FY: 2013 ( Subtotal = $990,669 )
2013	2013	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	2	5/28/2013	NON-COMPETING CONTINUATION	$42,155
2013	2013	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	2	4/12/2013	NON-COMPETING CONTINUATION	$948,514
														Subtotal = $990,669

Issue Date FY: 2012 ( Subtotal = $1,306,446 )
2012	2012	PROFECTUS BIOSCIENCES INC	6411 BECKLEY STREET	BALTIMORE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	1	4/26/2012	NEW	$1,306,446
														Subtotal = $1,306,446

Grand Total All Awards = $5,352,699

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Development of sG as a human vaccine against Nipah/Hendra

Award Number: R01AI098760

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: 12/31/2018

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer