Herpes Virus Infections in Kidney Transplant Patients

NCT05604911 | Active Not Recruiting

• 2 other identifiers: H-220426030073947
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Kidney Transplant; Complications; Varicella Zoster Virus Infection; Vaccine-Preventable Diseases

Keywords

Varicella Zoster Virus; Shingrix; Kidney transplant; Immune response; Varicella Zoster Virus infection; Herpes Zoster; Shingles; Humane Herpes Virus 3

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Kidney transplant patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Kidney transplant recipient transplanted after 2019-01-01 OR on the kidney transplant waitlist
• Has been offered Shingrix® vaccination

You may not qualify if:

• Lack of informed consent
• Inability to understand the study information

Sponsors & Collaborators

• Susanne Dam Nielsen, MD, DMSc: lead
• Technical University of Denmark: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (5)

Department of Nephrology, Aarhus University Hospital

Aarhus, Denmark

Location

Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Nephrology, Copehagen University Hospital - Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Health Technology, Technical University of Denmark

Lyngby, 2800, Denmark

Location

Department of Nephrology, Odense University Hospital

Odense, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37845608 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells (PBMC) and plasma samples will be collected and stored in a biobank.

MeSH Terms

Conditions

Varicella Zoster Virus Infection; Vaccine-Preventable Diseases; Chickenpox; Herpes Zoster

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Susanne D Nielsen, MD, DMSc

  Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet

  PRINCIPAL INVESTIGATOR

• Søren S Sørensen, MD, DMSc

  Department of Nephrology, Copenhagen University Hospital - Rigshospitalet

  STUDY CHAIR

• Claus Bistrup, MD, PhD

  Department of Nephrology, Odense University Hospital

  STUDY CHAIR

• Henrik Birn, MD, PhD, DMSc

  Department of Nephrology, Aarhus University Hospital

  STUDY CHAIR

• Sine R Hadrup, MSc, PhD

  Department of Health Technology, Technical University of Denmark

  STUDY CHAIR

• Annemette Hald, RN

  Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet

  STUDY DIRECTOR

• Sunil K Saini, MSc, PhD

  Department of Health Technology, Technical University of Denmark

  STUDY DIRECTOR

• Isik S Johansen, MD, DMSc

  Department of Infectious Diseases, Odense University Hospital

  STUDY DIRECTOR

• Helle Bruunsgaard, MD, PhD, DMSc

  Department of Clinical Immunology, Copenhagen University Hospital - Rigshospitalet

  STUDY DIRECTOR

• Carsten S Larsen, MD, DMSc

  Department of Infectious Diseases, Aarhus University Hospital

  STUDY DIRECTOR

• Zitta B Harboe, MD, PhD

  Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital - North Zealand

  STUDY DIRECTOR

• Moisés A Suarez Zdunek, MD

  Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet

  STUDY DIRECTOR

• Sebastian R Hamm, BSc.med.

  Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: November 3, 2022
• Study Start: January 1, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

DK (5)