NCT05604911|Active Not Recruiting
Herpes Virus Infections in Kidney Transplant Patients
HINT
Investigation of Kidney Transplant Patients for Antibodies and T-cells After Herpes Virus Vaccination and Infection
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HINT
Investigation of Kidney Transplant Patients for Antibodies and T-cells After Herpes Virus Vaccination and Infection
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Novo Nordisk Foundation
observational
280
1 country
5
Study Start
January 1, 2023
Actual (reported)Primary Completion
February 1, 2026
Actual (reported)Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Kidney transplant recipients are at increased risk of infections, including Varicella-zoster virus (VZV) infections. Vaccination against VZV is routinely offered to all kidney transplant recipients and candidates in Denmark. In this exploratory observational study, the VZV specific immune response in kidney transplant candidates and recipients will be characterized at different time points in relation to transplantation, vaccination and infections. More knowledge on the immune reaction to transplantation, VZV vaccination and VZV infections may provide improved strategies for prevention and treatment of VZV infections in kidney transplant candidates and recipients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 19, 2022
Actual (reported)November 3, 2022
Actual (reported)January 1, 2023
Actual (reported)February 1, 2026
Actual (reported)December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in levels of antibodies against Varicella-Zoster virus
Measurement of the change in levels of antibodies against Varicella-Zoster virus glycoprotein E using enzyme-linked immunosorbent assays (ELISA). The change will be assessed at regular intervals up to 12 months after inclusion or transplantation as well as well as in the case of infection.
12 months
Change in presence and function of Varicella-Zoster virus-specific T cells
Identification, phenotyping and cytokine profiling of Varicella-Zoster virus-specific T cells using DNA-barcode marking, flow cytometry and plasma cytokine profiles at regular intervals up to 12 months after inclusion or transplantation as well as in the case of infection.
12 months
Kidney transplant recipients transplanted after 2019-01-01 and kidney transplant candidates followed at Copenhagen University Hospital - Rigshospitalet, Aarhus University Hospital and Odense University Hospital who has been offered Shingrix® vaccination will be invited to participate
Department of Nephrology, Aarhus University Hospital
Aarhus, Denmark
Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100, Denmark
Department of Nephrology, Copehagen University Hospital - Rigshospitalet
Copenhagen, 2100, Denmark
Department of Health Technology, Technical University of Denmark
Lyngby, 2800, Denmark
Department of Nephrology, Odense University Hospital
Odense, Denmark
Hamm SR, Saini SK, Hald A, Vaaben AV, Pedersen NW, Suarez-Zdunek MA, Harboe ZB, Bruunsgaard H, Johansen IS, Larsen CS, Bistrup C, Birn H, Sorensen SS, Hadrup SR, Nielsen SD. Herpes Virus Infections in Kidney Transplant Patients (HINT) - a prospective observational cohort study. BMC Infect Dis. 2023 Oct 16;23(1):687. doi: 10.1186/s12879-023-08663-5.
Peripheral blood mononuclear cells (PBMC) and plasma samples will be collected and stored in a biobank.
Susanne D Nielsen, MD, DMSc
Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet
Søren S Sørensen, MD, DMSc
Department of Nephrology, Copenhagen University Hospital - Rigshospitalet
Claus Bistrup, MD, PhD
Department of Nephrology, Odense University Hospital
Henrik Birn, MD, PhD, DMSc
Department of Nephrology, Aarhus University Hospital
280 participants (actual enrollment reported by the registry).
First Submitted
September 19, 2022
First Posted
November 3, 2022
Study Start
January 1, 2023
Actual (reported)Contact the study team to confirm eligibility.
Sine R Hadrup, MSc, PhD
Department of Health Technology, Technical University of Denmark
Annemette Hald, RN
Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet
Sunil K Saini, MSc, PhD
Department of Health Technology, Technical University of Denmark
Isik S Johansen, MD, DMSc
Department of Infectious Diseases, Odense University Hospital
Helle Bruunsgaard, MD, PhD, DMSc
Department of Clinical Immunology, Copenhagen University Hospital - Rigshospitalet
Carsten S Larsen, MD, DMSc
Department of Infectious Diseases, Aarhus University Hospital
Zitta B Harboe, MD, PhD
Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital - North Zealand
Moisés A Suarez Zdunek, MD
Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet
Sebastian R Hamm, BSc.med.
Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet
Primary Completion
February 1, 2026
Actual (reported)Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 12, 2026
Record last verified: 2026-08
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