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mVACS--mRNA Vaccines for C. difficile Suppression

Award Number: U19AI174998
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: 03/01/2023
PERIOD OF PERFORMANCE END DATE: 02/29/2028

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mVACS--mRNA Vaccines for C. difficile Suppression - SUMMARY – mVACS PROGRAM Clostridioides difficile is the most reported nosocomial pathogen in the United States and a major public health threat worldwide. Challenges in treating infections with conventional antibiotics and increasing rates of recurrent infection underscore the need for new interventions. To date, no vaccine has proven to be effective at clearing C. difficile from infected individuals. The mVACS program— mRNA Vaccines for C. difficile Suppression”—is tightly focused on the goal of designing and implementing improved vaccines to mitigate or eliminate C. difficile infection (CDI). For this we will employ modified mRNA vaccine technology, which has been pioneered so successfully by team member Dr. Drew Weissman and his collaborators at BioNTech to immunize against SARS- CoV-2. Already Drs. Weissman, Alameh, and Zackular have established a collaboration with BioNTech to develop an mRNA targeting C. difficile toxins and other antigens and shown their lead formulation to be highly protective in mice challenged with a lethal dose of C. difficile. However, C. difficile is not fully cleared from the mice, and there is mild transient pathogenesis, so there is more to be done. The team is moving forward with this anti-toxin vaccine, but improvements in design are necessary for optimal efficacy. The mVACS team is a highly skilled and synergistic group dedicated to developing modified mRNAs to oppose C. difficile infection and pathogenesis. The program consists of three projects and three cores. Project 1 (Vaccine Development) (Project Leads: Alameh and Weissman) will test new mRNAs against multiple C. difficile targets, as well as mixtures of mRNAs and novel nanoparticle/lipid formulations. Project 2 (Antigen Discovery) (Project Lead: Zackular) will take advantage of advanced analysis of C. difficile microbiology and ecology of infection to produce a series of novel vaccine targets. Project 3 (Immunology) (Project Lead: Abt) will quantify mucosal adaptive immune responses against C. difficile in humans and mouse systems, identifying gaps and correlates of efficacy. Projects 2 (Antigen Discovery) and Project 3 (Immunology) will flow new data to Project 1 (Vaccine Development) to optimize vaccine design. The Projects will be complemented by three Cores: Core A (Administrative Core) (Core Leads: Bushman and Weissman), Core B (Genomics Core) (Core Leads: Bittinger, Bushman, and Moustafa) and Core C (Clinical Core) (Core Leads: Kelly and Conrad). Together with our industry partner BioNTech, we are highly optimistic that we can advance effective new vaccine designs to suppress C. difficile.


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 = $1,529,954 )
2025	2025	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Allergy and Infectious Diseases Research	000	3	4/14/2025	NON-COMPETING CONTINUATION	$1,529,954
														Subtotal = $1,529,954

Issue Date FY: 2024 ( Subtotal = $1,529,954 )
2024	2024	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Allergy and Infectious Diseases Research	001	2	4/18/2024	NON-COMPETING CONTINUATION	$152,995
2024	2024	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Allergy and Infectious Diseases Research	000	2	2/16/2024	NON-COMPETING CONTINUATION	$1,376,959
														Subtotal = $1,529,954

Issue Date FY: 2023 ( Subtotal = $1,529,954 )
2023	2023	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Allergy and Infectious Diseases Research	000	1	2/21/2023	NEW	$1,529,954
														Subtotal = $1,529,954

Grand Total All Awards = $4,589,862

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mVACS--mRNA Vaccines for C. difficile Suppression

Award Number: U19AI174998

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: 03/01/2023

PERIOD OF PERFORMANCE END DATE: 02/29/2028

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