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Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant candidates (COLT)

Award Number: U01AI163090
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: 08/26/2021
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant candidates (COLT) - PROJECT SUMMARY : Cytomegalovirus (CMV) has a major negative impact in solid organ transplant recipients (SOTxR) due to limitations in current preventive and therapeutic strategies, especially in CMV seronegative recipients (R-) of organs from seropositive donors (D+) [D+R-]. The D+R- subset comprises ~25% of all SOTxR but >80% of CMV disease and is independently associated with worse long-term survival after SOTx. The disproportionate impact in D+R- SOTxR results from an impaired ability to develop a primary immune response to donor-transmitted CMV infection in the context of immunosuppression. Strategies that elicit or enhance CMV-specific immunity prior to SOTx could lead to more effective prevention/control of CMV after SOTx, minimizing the need for toxic CMV antiviral therapy (AVT). We have developed a modified vaccinia Ankara virus vaccine, Triplex, that expresses immunodominant CMV antigens pp65, IE-1, and IE-2 that are targets of protective T cell immunity. Triplex elicits robust, long-lasting, and functional CMV-specific CD4 and CD8 T cells. Triplex was safe, accelerated reconstitution of CMV protective immunity, and reduced significant CMV infection by ~50% in a phase 2 study of allogeneic hematopoietic cell TxR. Our long-term goals are to harness vaccine-induced CMV- specific cellular immunity to reduce the impact of CMV in D+R- SOTxR and to define immune correlates of risk (CoR) and for protection (CoP) (i.e. immune correlates of Triplex vaccine efficacy [VE]). The central hypothesis is that pre-Tx Triplex vaccination of CMV seronegative LTx candidates elicits functional CMV-specific CD4 and CD8 T cells, leading to improved immune control of CMV and significantly decreases the need for CMV AVT post- Tx in D+R- LTxR who receive preemptive therapy (PET) for CMV prevention. We further hypothesize that there are specific immune CoR for CMV outcomes and CoP of Triplex vaccine. We will leverage our established consortium and preliminary studies in a target population of D+R- LTxR with high unmet need (no FDA-approved available antiviral prophylaxis options, highly susceptible to valganciclovir toxicity, and significant CMV- associated morbidity, mortality, and cost). The objectives of this proposal are to assess the efficacy, safety and immunogenicity of Triplex in D+R- LTxR in a phase 2 study and to define the immune CoR and CoP using state- of-the-art polyfunctional T cell assays and novel analytic approaches (COMbinatorial Polyfunctionality analysis of Antigen-Specific T cell Subsets [COMPASS]). An effective pre-Tx CMV vaccination approach would transform CMV prevention strategies in SOTx. The proposed studies will define immune CoR for clinical outcomes, which will facilitate efficient evaluation of future immune-based strategies, and lead to broader implementation of the more effective PET CMV prevention strategy in D+R- LTxR.


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 = $3,209,830 )
2025	2025	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	002	6	6/6/2025	NON-COMPETING CONTINUATION	$3,209,830
2025	2024	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	000	4	3/14/2025	NON-COMPETING CONTINUATION	-$2,672,910
2025	2024	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	005	4	6/9/2025	NON-COMPETING CONTINUATION	-$658,822
2025	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	006	5	6/9/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$5,970,440
2025	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	001	5	3/14/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$2,672,910
2025	2023	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	004	3	6/9/2025	NON-COMPETING CONTINUATION	-$3,331,802
2025	2022	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	003	2	6/9/2025	NON-COMPETING CONTINUATION	-$1,979,816
														Subtotal = $3,209,830

Issue Date FY: 2024 ( Subtotal = $3,331,732 )
2024	2024	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	000	4	5/21/2024	NON-COMPETING CONTINUATION	$3,331,732
														Subtotal = $3,331,732

Issue Date FY: 2023 ( Subtotal = $3,331,802 )
2023	2023	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	000	3	5/19/2023	NON-COMPETING CONTINUATION	$3,331,802
														Subtotal = $3,331,802

Issue Date FY: 2022 ( Subtotal = $3,354,504 )
2022	2022	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	002	2	9/12/2022	NON-COMPETING CONTINUATION	$0
2022	2022	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	001	2	6/27/2022	NON-COMPETING CONTINUATION	$3,354,504
2022	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	000	1	11/18/2021	NEW	$0
														Subtotal = $3,354,504

Issue Date FY: 2021 ( Subtotal = $2,295,742 )
2021	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	000	1	8/26/2021	NEW	$2,295,742
														Subtotal = $2,295,742

Grand Total All Awards = $15,523,610

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Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant candidates (COLT)

Award Number: U01AI163090

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: 08/26/2021

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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