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PERSISTENCE OF IMMUNE RESPONSES TO THE RECOMBINANT ZOSTER VACCINE IN IMMUNE COMPROMISED HOSTS WITH END-STAGE RENAL DISEASE WITH AND WITHOUT KIDNEY TRANSPLANTATION

Award Number: U01AI141919
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: 03/06/2019
PERIOD OF PERFORMANCE END DATE: 02/28/2029

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PERSISTENCE OF IMMUNE RESPONSES TO THE RECOMBINANT ZOSTER VACCINE IN IMMUNE COMPROMISED HOSTS WITH END-STAGE RENAL DISEASE WITH AND WITHOUT KIDNEY TRANSPLANTATION - Project Summary People with immunocompromising conditions, including end stage renal disease (ESRD) and renal transplantation, are at increased risk of developing severe infections. Vaccination is the preferred mode of protection against infections but people with the highest risk of infectious morbidity tend to have poor responses to vaccines. The recombinant zoster vaccine (RZV) showed excellent efficacy in healthy adults ≥50 years of age and lower immunogenicity and efficacy in transplant recipients. The goal of this study is to define the immunologic and metabolomic profiles associated with decreased magnitude and persistence of immune responses to RZV in people with ESRD before and after transplantation. We will use plasma and PBMC collected in a study of RZV in ESRD sponsored by GlaxoSmithKline, in which participants receive the standard 2-dose RZV immunization regimen while awaiting renal transplantation and are then followed for 31 months. Transplanted participants on stable immunosuppression are randomized to receive a 3rd dose of RZV or not and are followed for 12 additional months. Responses of these immunocompromised hosts are compared with responses of healthy adults ≥50 years of age, who received RZV in previous studies. Research questions will be addressed in the following Aims: Aim 1. Identify immunologic and metabolomic correlates of reduced persistence of immune responses to RZV in people with ESRD. We will compare adaptive and innate memory responses to RZV in 50 ESRD and 50 healthy older adults using flow cytometric and single cell immunogenomic approaches and identify factors associated with persistence. Using systems and computational immunology approaches, we will identify pre- vaccination phenotypic, functional, and genomic immune cell profiles, and inflammatory and metabolomic characteristics associated with decreased responses to RZV in people with ESRD. Associations of inflammatory factors and/or metabolites with characteristics that hamper the immune responses to RZV will be verified in vitro. Aim 2. Define the effect of renal transplantation and of a 3rd dose of vaccine on immune responses to RZV. We will compare adaptive and innate memory responses to a 3rd dose of RZV administered to 30 transplant recipients with responses to the standard RZV regimen in 50 healthy and 50 ESRD older adults using flow cytometry and single cell immunogenomics. We will analyze the T-cell repertoire to define the effect of induction regimens and of the 3rd dose of RZV on the persistence of RZV-expanded T cell clones. We will determine pre- vaccination immunologic and metabolomic profiles associated with responses to the 3rd dose of RZV in transplant recipients. Impact. This study will identify actionable inflammatory and/or metabolomic factors and immunogenomic characteristics associated with decreased responses to RZV in people with ESRD with and without transplantation and will determine if a 3rd dose of RZV can mitigate the negative effect of transplantation on the persistence of immune responses to RZV. We will leverage prior NIH- and GlaxoSmithKline-funded studies.


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: 2026 ( Subtotal = $788,746 )
2026	2026	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	000	8	2/13/2026	NON-COMPETING CONTINUATION	$788,746
														Subtotal = $788,746

Issue Date FY: 2025 ( Subtotal = $765,085 )
2025	2025	THE REGENTS OF THE UNIV. OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	002	7	2/13/2025	NON-COMPETING CONTINUATION	$765,085
2025	2024	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	001	6	11/14/2024	COMPETING CONTINUATION	$0
2025	2023	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	000	5	11/7/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $765,085

Issue Date FY: 2024 ( Subtotal = $704,735 )
2024	2024	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	001	6	1/22/2024	COMPETING CONTINUATION	$704,735
2024	2023	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	000	5	1/10/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $704,735

Issue Date FY: 2023 ( Subtotal = $685,272 )
2023	2023	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	000	5	2/22/2023	NON-COMPETING CONTINUATION	$685,272
														Subtotal = $685,272

Issue Date FY: 2022 ( Subtotal = $699,825 )
2022	2022	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	000	4	2/25/2022	NON-COMPETING CONTINUATION	$699,825
														Subtotal = $699,825

Issue Date FY: 2021 ( Subtotal = $704,995 )
2021	2021	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	000	3	3/3/2021	NON-COMPETING CONTINUATION	$704,995
														Subtotal = $704,995

Issue Date FY: 2020 ( Subtotal = $715,495 )
2020	2020	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	000	2	2/21/2020	NON-COMPETING CONTINUATION	$715,495
														Subtotal = $715,495

Issue Date FY: 2019 ( Subtotal = $729,245 )
2019	2019	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	001	1	6/7/2019	NEW	$0
2019	2019	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Allergy and Infectious Diseases Research	000	1	3/5/2019	NEW	$729,245
														Subtotal = $729,245

Grand Total All Awards = $5,793,398

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PERSISTENCE OF IMMUNE RESPONSES TO THE RECOMBINANT ZOSTER VACCINE IN IMMUNE COMPROMISED HOSTS WITH END-STAGE RENAL DISEASE WITH AND WITHOUT KIDNEY TRANSPLANTATION

Award Number: U01AI141919

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: 03/06/2019

PERIOD OF PERFORMANCE END DATE: 02/28/2029

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