Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in chronically immunosuppressed adults following renal transplant : A phase 3, randomized clinical trial

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Vink , P , Torrell , J M R , Fructuoso , A S , Kim , S-J , Kim , S-I , Zaltzman , J , Ortiz , F , Plana , J M C , Rodriguez , A M F , Rodrigo , H R , Marti , M C , Perez , R , Roncero , F M G , Kumar , D , Chiang , Y-J , Doucette , K , Pipeleers , L , Morales , M L A , Rodriguez-Ferrero , M L , Secchi , A , McNeil , S A , Campora , L , Di Paolo , E , El Idrissi , M , López-Fauqued , M , Salaun , B , Heineman , T C & Oostvogels , L 2020 , ' Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in chronically immunosuppressed adults following renal transplant : A phase 3, randomized clinical trial ' , Clinical Infectious Diseases , vol. 70 , no. 2 , pp. 181-190 . https://doi.org/10.1093/cid/ciz177

Title: Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in chronically immunosuppressed adults following renal transplant : A phase 3, randomized clinical trial
Author: Vink, P.; Torrell, J.M.R.; Fructuoso, A.S.; Kim, Sung-Joo; Kim, Sang-Il; Zaltzman, J.; Ortiz, F.; Plana, J.M.C.; Rodriguez, A.M.F.; Rodrigo, H.R.; Marti, M.C.; Perez, R.; Roncero, F.M.G.; Kumar, D.; Chiang, Y.-J.; Doucette, K.; Pipeleers, L.; Morales, M.L.A.; Rodriguez-Ferrero, M.L.; Secchi, Antonio; McNeil, S.A.; Campora, L.; Di Paolo, E.; El Idrissi, M.; López-Fauqued, M.; Salaun, B.; Heineman, T.C.; Oostvogels, L.
Contributor: University of Helsinki, Clinicum
Date: 2020-01-15
Language: eng
Number of pages: 10
Belongs to series: Clinical Infectious Diseases
ISSN: 1058-4838
URI: http://hdl.handle.net/10138/327850
Abstract: Background. The incidence of herpes zoster is up to 9 times higher in immunosuppressed solid organ transplant recipients than in the general population. We investigated the immunogenicity and safety of an adjuvanted recombinant zoster vaccine (RZV) in renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy. Methods. In this phase 3, randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled and received 2 doses of RZV or placebo 1-2 months (M) apart 4-18M posttransplant. Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates were assessed at 1M post-dose 1, and 1M and 12M post-dose 2. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Solicited general symptoms and unsolicited AEs were also collected 7 days before first vaccination. Serious AEs (including biopsy-proven allograft rejections) and potential immune-mediated diseases (pIMDs) were recorded up to 12M post-dose 2. Results. Two hundred sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 and April 2017. gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across postvaccination time points and persisted above prevaccination baseline 12M post-dose 2. Local AEs were reported more frequently by RZV than placebo recipients. Overall occurrences of renal function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were similar between groups. Conclusions. RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose. © The Author(s) 2019.
Subject: Herpes zoster vaccine
Immunogenicity
Immunosuppression
Renal transplant
Safety
calcineurin inhibitor
CD4 antigen
corticosteroid
creatinine
glycoprotein E
mycophenolic acid
placebo
rapamycin
recombinant vaccine
varicella zoster vaccine
virus antibody
abdominal pain
adult
antibody titer
Article
bacterial meningitis
Burkitt lymphoma
CD4+ T lymphocyte
cellular immunity
controlled study
diarrhea
drug fatality
drug safety
fatigue
febrile neutropenia
female
fever
gastrointestinal symptom
graft recipient
human
humoral immunity
immune deficiency
immunosuppressive treatment
injection site erythema
injection site pain
injection site swelling
kidney function
kidney graft
kidney graft rejection
major clinical study
male
mucosa inflammation
multicenter study
myalgia
nausea
phase 3 clinical trial
priority journal
randomized controlled trial
shivering
side effect
single blind procedure
vaccination
vaccine immunogenicity
vomiting
clinical trial
herpes zoster
kidney transplantation
Varicella zoster virus
Adult
Antibodies, Viral
Herpes Zoster
Herpes Zoster Vaccine
Herpesvirus 3, Human
Humans
Immunogenicity, Vaccine
Kidney Transplantation
Vaccines, Synthetic
11832 Microbiology and virology
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