TY - T1 - Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in chronically immunosuppressed adults following renal transplant : A phase 3, randomized clinical trial SN - / UR - http://hdl.handle.net/10138/327850 T3 - A1 - 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. A2 - PB - Y1 - 2020 LA - eng AB - 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 month... VO - IS - SP - OP - KW - 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 N1 - PP - ER -