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A Randomized Phase I Clinical Trial of HydroVax-CHIKV, a Novel Inactivated Chikungunya Virus Vaccine

Award Number: U44AI152995
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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A Randomized Phase I Clinical Trial of HydroVax-CHIKV, a Novel Inactivated Chikungunya Virus Vaccine - Chikungunya virus (CHIKV) is an alphavirus that has gained significant attention due to its ability to cause large epidemics among susceptible populations and to be spread beyond endemic countries by international travelers. Among a population of approximately 750,000 on the French island of La Reunion, 266,000 people were infected and over 200 CHIKV-related fatalities occurred during the 2006 outbreak. Likewise, an estimated 1.4 million people were infected with CHIKV in India during outbreaks that occurred from 2006 to 2007 and recently there have been more than 1.7 million people infected with CHIKV in the Caribbean and the Americas. At present, there is no commercial vaccine available for CHIKV. The development of an inactivated CHIKV vaccine suitable for immunizing the general population as well as vulnerable groups including infants and the elderly represents an important unmet clinical need. To address this critical unmet need, we have discovered a safe and immunogenic peroxide-inactivated chikungunya virus vaccine, HydroVax-CHIKV. Importantly, this advanced vaccine is safe and provides complete protection against infection and CHIKV-associated pathology in a robust mouse model. Here, we propose a double-blind, randomized, placebo-controlled Phase 1 dose escalation trial to evaluate the preliminary safety and immunogenicity of HydroVax-CHIKV. Our goal is to eventually provide vaccine coverage to vulnerable populations and the successful completion of this study will represent a key milestone in the advancement of a clinically relevant vaccine against chikungunya virus and provide a much- needed approach to protect the most susceptible members of society including infants, elderly, and those with potentially compromised immune functions.


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: 2024 ( Subtotal = $986,133 )
2024	2024	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	001	2	7/22/2024	EXTENSION WITH OR WITHOUT FUNDS	$985,958
2024	2024	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	002	2	7/29/2024	EXTENSION WITH OR WITHOUT FUNDS	$175
2024	2020	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	000	1	11/16/2023	NEW	$0
														Subtotal = $986,133

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	000	1	1/7/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $290,420 )
2020	2020	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	000	1	6/30/2020	NEW	$290,420
														Subtotal = $290,420

Grand Total All Awards = $1,276,553

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A Randomized Phase I Clinical Trial of HydroVax-CHIKV, a Novel Inactivated Chikungunya Virus Vaccine

Award Number: U44AI152995

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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