Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial.

Autor:	Vink P; GlaxoSmithKline (GSK), Rockville, Maryland., Ramon Torrell JM; Bellvitge University Hospital, Barcelona., Sanchez Fructuoso A; Hospital Clínico San Carlos, Madrid, Spain., Kim SJ; Sungkyunkwan University, Canada., Kim SI; Seoul St Mary's Hospital, College of Medicine, Catholic University of Korea, Republic of Korea., Zaltzman J; St Michael's Hospital, University of Toronto, Ontario, Canada., Ortiz F; Helsinki University Hospital, Finland., Campistol Plana JM; Hospital Clinic, University of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer., Fernandez Rodriguez AM; Hospital Ramón y Cajal, Madrid., Rebollo Rodrigo H; University Hospital Valdecilla, Santander., Campins Marti M; Hospital Universitario Vall d'Hebron, Barcelona, Spain., Perez R; Social Security of Panama, Panama City., González Roncero FM; Hospital Universitario Virgen Rocio, Sevilla, Spain., Kumar D; University Health Network, Toronto, Ontario, Canada., Chiang YJ; Chang Gung Memorial Hospital, Taoyuan, Taiwan., Doucette K; University of Alberta, Edmonton, Canada., Pipeleers L; UZ Brussel, Belgium., Agüera Morales ML; Hospital Universitario Reina Sofia, Córdoba., Rodriguez-Ferrero ML; Hospital General Universitario Gregorio Marañón, Madrid, Spain., Secchi A; Vita Salute San Reffaele University, Milan, Italy., McNeil SA; Canadian Center for Vaccinology, Izaak Walton Killam Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Canada., Campora L; GSK, Wavre, Belgium., Di Paolo E; GSK, Rixensart, Belgium., El Idrissi M; GSK, Rixensart, Belgium., López-Fauqued M; GSK, Wavre, Belgium., Salaun B; GSK, Rixensart, Belgium., Heineman TC; GSK, King of Prussia, Pennsylvania., Oostvogels L; GSK, Wavre, Belgium.
Jazyk:	angličtina
Zdroj:	Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2020 Jan 02; Vol. 70 (2), pp. 181-190.
DOI:	10.1093/cid/ciz177
Abstrakt:	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. Clinical Trials Registration: NCT02058589. (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.)
Databáze:	MEDLINE
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