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|Title:||Immunogenicity and safety of adjuvanted recombinant zoster vaccine in chronically immunosuppresed adults following renal transplant: A phase III, randomized clinical trial|
Ramon Torrell, Josep M. (Josep Maria)
Sánchez Fructuoso, Ana
Campistol Plana, Josep M.
Fernandez Rodriguez, Ana Maria
Rebollo Rodrigo, Henar
Campins Marti, Magda
González Roncero, Francisco Manuel
Agüera Morales, Maria Luisa
Rodriguez-Ferrero, Maria Luisa
McNeil, Shelly A.
Paolo, Emmanuel Di
Idrissi, Mohamed El
Heineman, Thomas C.
Z-041 Study Group
|Publisher:||Oxford University Press|
|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 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 III, randomized (1:1), observer-blind, multicenter trial (NCT02058589), RT recipients were enrolled and received 2 doses of RZV or Placebo 1-2 months (M) apart 4-18M post-transplant. 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 post-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: 264 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 post-vaccination time points and persisted above pre-vaccination 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, SAEs, and pIMDs were similar between groups. Conclusions: RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M post-vaccination. No safety concerns arose.|
|Note:||Reproducció del document publicat a: https://doi.org/10.1093/cid/ciz177|
|It is part of:||Clinical Infectious Diseases, 2019, vol. 70, num. 2, p. 181-190|
|Appears in Collections:||Articles publicats en revistes (Ciències Clíniques)|
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
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