TY - JOUR

T1 - Herpes Virus Infections in Kidney Transplant Patients (HINT) – a prospective observational cohort study

AU - Hamm, Sebastian Rask

AU - Saini, Sunil Kumar

AU - Hald, Annemette

AU - Vaaben, Anna V.

AU - Pedersen, Natasja Wulff

AU - Suarez-Zdunek, Moises Alberto

AU - Harboe, Zitta Barrella

AU - Bruunsgaard, Helle

AU - Johansen, Isik Somuncu

AU - Larsen, Carsten Schade

AU - Bistrup, Claus

AU - Birn, Henrik

AU - Sørensen, Søren Schwartz

AU - Hadrup, Sine Reker

AU - Nielsen, Susanne Dam

N1 - Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.

PY - 2023

Y1 - 2023

N2 - Background: Kidney transplant recipients receive maintenance immunosuppressive therapy to avoid allograft rejection resulting in increased risk of infections and infection-related morbidity and mortality. Approximately 98% of adults are infected with varicella zoster virus, which upon reactivation causes herpes zoster. The incidence of herpes zoster is higher in kidney transplant recipients than in immunocompetent individuals, and kidney transplant recipients are at increased risk of severe herpes zoster-associated disease. Vaccination with adjuvanted recombinant glycoprotein E subunit herpes zoster vaccine (RZV) prevents herpes zoster in older adults with excellent efficacy (90%), and vaccination of kidney transplant candidates is recommended in Danish and international guidelines. However, the robustness and duration of immune responses after RZV vaccination, as well as the optimal timing of vaccination in relation to transplantation remain unanswered questions. Thus, the aim of this study is to characterize the immune response to RZV vaccination in kidney transplant candidates and recipients at different timepoints before and after transplantation. Methods: The Herpes Virus Infections in Kidney Transplant Patients (HINT) study is a prospective observational cohort study. The study will include kidney transplant candidates on the waiting list for transplantation (n = 375) and kidney transplant recipients transplanted since January 1, 2019 (n = 500) from all Danish kidney transplant centers who are offered a RZV vaccine as routine care. Participants are followed with repeated blood sampling until 12 months after inclusion. In the case of transplantation or herpes zoster disease, additional blood samples will be collected until 12 months after transplantation. The immune response will be characterized by immunophenotyping and functional characterization of varicella zoster virus-specific T cells, by detection of anti-glycoprotein E antibodies, and by measuring cytokine profiles. Discussion: The study will provide new knowledge on the immune response to RZV vaccination in kidney transplant candidates and recipients and the robustness and duration of the response, potentially enhancing preventive strategies against herpes zoster in a population at increased risk. Trial registration: ClinicalTrials.gov (NCT05604911).

AB - Background: Kidney transplant recipients receive maintenance immunosuppressive therapy to avoid allograft rejection resulting in increased risk of infections and infection-related morbidity and mortality. Approximately 98% of adults are infected with varicella zoster virus, which upon reactivation causes herpes zoster. The incidence of herpes zoster is higher in kidney transplant recipients than in immunocompetent individuals, and kidney transplant recipients are at increased risk of severe herpes zoster-associated disease. Vaccination with adjuvanted recombinant glycoprotein E subunit herpes zoster vaccine (RZV) prevents herpes zoster in older adults with excellent efficacy (90%), and vaccination of kidney transplant candidates is recommended in Danish and international guidelines. However, the robustness and duration of immune responses after RZV vaccination, as well as the optimal timing of vaccination in relation to transplantation remain unanswered questions. Thus, the aim of this study is to characterize the immune response to RZV vaccination in kidney transplant candidates and recipients at different timepoints before and after transplantation. Methods: The Herpes Virus Infections in Kidney Transplant Patients (HINT) study is a prospective observational cohort study. The study will include kidney transplant candidates on the waiting list for transplantation (n = 375) and kidney transplant recipients transplanted since January 1, 2019 (n = 500) from all Danish kidney transplant centers who are offered a RZV vaccine as routine care. Participants are followed with repeated blood sampling until 12 months after inclusion. In the case of transplantation or herpes zoster disease, additional blood samples will be collected until 12 months after transplantation. The immune response will be characterized by immunophenotyping and functional characterization of varicella zoster virus-specific T cells, by detection of anti-glycoprotein E antibodies, and by measuring cytokine profiles. Discussion: The study will provide new knowledge on the immune response to RZV vaccination in kidney transplant candidates and recipients and the robustness and duration of the response, potentially enhancing preventive strategies against herpes zoster in a population at increased risk. Trial registration: ClinicalTrials.gov (NCT05604911).

KW - Adjuvanted recombinant glycoprotein E subunit herpes zoster vaccine

KW - Herpes zoster

KW - Humane herpes virus 3

KW - Immune response

KW - Immunodominant epitopes

KW - Kidney transplant candidates

KW - Kidney transplant recipients

KW - Shingles

KW - Shingrix

KW - T-Lymphocytes

KW - Varicella zoster virus

U2 - 10.1186/s12879-023-08663-5

DO - 10.1186/s12879-023-08663-5

M3 - Journal article

C2 - 37845608

AN - SCOPUS:85174285093

VL - 23

JO - B M C Infectious Diseases

JF - B M C Infectious Diseases

SN - 1471-2334

IS - 1

M1 - 687

ER -