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A Randomized Phase I Clinical Trial of HydroVax-YFV, a Novel Inativated Yellow Fever Vaccine

Award Number: U44AI145791
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: 07/01/2019
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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A Randomized Phase I Clinical Trial of HydroVax-YFV, a Novel Inativated Yellow Fever Vaccine - Abstract Yellow fever virus (YFV) is a mosquito-borne emerging/re-emerging hemorrhagic fever virus that causes 20- 60% mortality and is endemic in >40 countries. The current live attenuated YFV vaccine was developed in 1936 and has proven to be effective at saving millions of lives from this devastating disease. Nevertheless, this is a live-attenuated vaccine that is contraindicated in healthy people who have egg allergies as well as vulnerable populations including young infants, pregnant or breastfeeding women, and the elderly. During recent outbreaks, these at-risk groups have had no alternatives to live yellow fever vaccination and our goal is to produce a vaccine that is safe for both healthy and vulnerable populations. According to the CDC, live YFV vaccines cause 47 serious adverse events (SAE) per million vaccinations (SAE defined as resulting in hospitalization, long-term disability, or death). Vaccine-associated neurological disease occurs at a rate of up to 1 case per 10,000 vaccinations. YFV vaccination of infants <9 months of age has been contraindicated since the 1960’s due to excessively high rates of vaccine-associated encephalitis in this age group. More recently, live YFV vaccination has been contraindicated in breastfeeding mothers due to documented cases of virus transmission via breastmilk to infants who later developed YFV-associated neurological disease including seizures. In patients >60 years of age, YFV vaccination causes severe viscerotropic disease at an incidence rate of approximately 1:50,000 with a mortality rate of >50%. The overall mortality rate following YFV vaccination (all ages) is estimated at 1 to 2 deaths per million doses. Despite these clear gaps in vaccination coverage, there is currently no commercial vaccine available for these vulnerable populations. To address this critical unmet need, we have discovered a safe and immunogenic peroxide-inactivated yellow fever vaccine, HydroVax-YFV. Importantly, this advanced vaccine is safe and provides complete protection against lethal viscerotropic yellow fever in a robust non-human primate model. Here, we propose a double-blind, randomized, placebo-controlled Phase I dose escalation trial to evaluate the preliminary safety and immunogenicity of HydroVax-YFV. Our goal is to eventually expand vaccine coverage to a broader range of patients and the successful completion of this study will represent a key milestone in the advancement of a clinically relevant vaccine against yellow fever 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: 2025 ( Subtotal = $0 )
2025	2023	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	000	4	8/4/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $825,048 )
2023	2023	NAJIT TECHNOLOGIES INC	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	000	4	7/12/2023	NON-COMPETING CONTINUATION	$825,048
														Subtotal = $825,048

Issue Date FY: 2022 ( Subtotal = $997,662 )
2022	2022	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	001	3	6/27/2022	NON-COMPETING CONTINUATION	$997,662
2022	2019	NAJIT TECHNOLOGIES INC	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	000	1	12/7/2021	NEW	$0
														Subtotal = $997,662

Issue Date FY: 2021 ( Subtotal = $999,652 )
2021	2021	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	002	2	7/2/2021	EXTENSION WITH OR WITHOUT FUNDS	$999,652
2021	2021	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	003	2	7/26/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
2021	2019	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	001	1	7/2/2021	NEW	$0
2021	2019	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	000	1	2/5/2021	NEW	$0
														Subtotal = $999,652

Issue Date FY: 2019 ( Subtotal = $292,140 )
2019	2019	NAJIT TECHNOLOGIES, INC.	15232 NW GREENBRIER PKWY	BEAVERTON	OR	97006	WASHINGTON	USA	Allergy and Infectious Diseases Research	000	1	6/14/2019	NEW	$292,140
														Subtotal = $292,140

Grand Total All Awards = $3,114,502

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A Randomized Phase I Clinical Trial of HydroVax-YFV, a Novel Inativated Yellow Fever Vaccine

Award Number: U44AI145791

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: 07/01/2019

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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