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Clin Infect Dis. 2019 Mar 7. pii: ciz177. doi: 10.1093/cid/ciz177. [Epub ahead of print]

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

Author information

1
GSK, Rockville, MD, US.
2
Bellvitge University Hospital, Barcelona, Spain.
3
Hospital Clínico San Carlos, Madrid, Spain.
4
Sungkyunkwan University, Seoul, Republic of Korea.
5
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
6
St. Michael's Hospital, University of Toronto, ON, Canada.
7
Helsinki University Hospital, Helsinki, Finland.
8
Hospital Clinic, University of Barcelona, IDIBAPS, Barcelona, Spain.
9
Hospital Ramón y Cajal, Madrid, Spain.
10
University Hospital Valdecilla, Santander, Spain.
11
Hospital Universitario Vall d'Hebron, Barcelona, Spain.
12
Social Security of Panama, Panama, Panama.
13
Hospital Universitario Virgen Rocio, Sevilla, Spain.
14
University Health Network, Toronto, ON, Canada.
15
Chang Gung Memorial Hospital, Taoyuan, Taiwan.
16
University of Alberta, Edmonton, AB, Canada.
17
UZ Brussel, Brussels, Belgium.
18
Hospital Universitario Reina Sofia, Córdoba, Spain.
19
Hospital General Universitario Gregorio Marañón, Madrid, Spain.
20
Vita Salute San Reffaele University, Milan, Italy.
21
Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Canada.
22
GSK, Wavre, Belgium.
23
GSK, Rixensart, Belgium.
24
GSK, King of Prussia, PA, USA.
25
Halozyme Therapeutics, San Diego, CA, USA.
26
CureVac AG, Tübingen, Germany.

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.

KEYWORDS:

herpes zoster vaccine; immunogenicity; immunosuppression; renal transplant; safety

PMID:
30843046
DOI:
10.1093/cid/ciz177

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