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An Informed Approach to Live Attenuated Vaccines against Encephalitis Alphaviruses

Award Number: R01AI153209
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: 06/12/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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An Informed Approach to Live Attenuated Vaccines against Encephalitis Alphaviruses - ABSTRACT Eastern (EEEV), Venezuelan (VEEV), and Western (WEEV) equine encephalitis viruses are mosquito-transmitted alphaviruses with the potential to cause fatal neuroinvasive disease in humans and domesticated animals. These viruses also can be spread by the aerosol route and thus, have significant potential as biowarfare/bioterrorism agents. In 2019, EEEV human infections increased to levels not seen since the 1950s. Currently, there are no antiviral therapies or vaccines licensed for these alphaviruses. The existing investigational live-attenuated VEEV vaccine (LAV; TC-83) was generated >40 years ago, is highly reactogenic, poorly immunogenic, and causes disease in up to 20% of recipients. For EEEV and WEEV, investigational formalin-inactivated vaccines have been given to at-risk workers. While both elicit antibody responses, they provide uncertain protection and require multiple booster injections. A trivalent veterinary vaccine against VEEV, EEEV and WEEV is available but is so poorly immunogenic that domestic animals must be boosted annually and disease is seen in vaccinated animals. Here, we propose to develop safe and effective LAVs vaccine against these alphaviruses using recent advances in understanding of the virulence mechanisms of each. These advances will allow mutagenesis of pathogenicity domains that specifically reduce virulence, increase cytokine induction and antigen presentation and provide long-lasting protection. Furthermore, the mechanism of action of each mutation will be known and each will be specifically designed to resist reversion. We will combine mutations to create an optimal vaccine strain for each virus and then investigate their use in multivalent formulations, critical to veterinary vaccine development and highly desired for human formulations. We will identify correlates of protection for each vaccine and address the extent of cross-protection versus encephalitic viruses. For the first time with alphaviruses, the individual and combined effects of mutations with known mechanisms of action will be tested for effects on virus replication, disease and immunogenicity in animals.


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: 2027 ( Subtotal = -$12,739 )
2027	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Allergy and Infectious Diseases Research	000	5	10/19/2026	NON-COMPETING CONTINUATION	-$12,739
														Subtotal = -$12,739

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Allergy and Infectious Diseases Research	000	5	8/5/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $485,811 )
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Allergy and Infectious Diseases Research	000	5	5/15/2024	NON-COMPETING CONTINUATION	$485,811
														Subtotal = $485,811

Issue Date FY: 2023 ( Subtotal = $486,606 )
2023	2023	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Allergy and Infectious Diseases Research	000	4	5/25/2023	NON-COMPETING CONTINUATION	$486,606
														Subtotal = $486,606

Issue Date FY: 2022 ( Subtotal = $939,630 )
2022	2022	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Allergy and Infectious Diseases Research	000	3	6/3/2022	NON-COMPETING CONTINUATION	$484,389
2022	2022	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Allergy and Infectious Diseases Research	001	3	8/24/2022	SUPPLEMENT FOR EXPANSION	$455,241
														Subtotal = $939,630

Issue Date FY: 2021 ( Subtotal = $477,720 )
2021	2021	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Allergy and Infectious Diseases Research	000	2	5/14/2021	NON-COMPETING CONTINUATION	$477,720
														Subtotal = $477,720

Issue Date FY: 2020 ( Subtotal = $472,242 )
2020	2020	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Allergy and Infectious Diseases Research	000	1	6/10/2020	NEW	$472,242
														Subtotal = $472,242

Grand Total All Awards = $2,849,270

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An Informed Approach to Live Attenuated Vaccines against Encephalitis Alphaviruses

Award Number: R01AI153209

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: 06/12/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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