Abstract

Background

The efficacy of the non-live adjuvanted recombinant zoster vaccine (RZV, containing a truncated form of varicella-zoster glycoprotein E [gE] and Adjuvant System AS01B) is >90% in adults ≥50 years of age (YOA) (ZOE-50/70) and >68% in hematopoietic stem cell transplant recipients ≥18 YOA (ZOE-HSCT).1 This study (NCT02058589) evaluated immunogenicity and safety of RZV in renal transplant recipients ≥18 YOA receiving immunosuppressive therapy. Previously unreported reactogenicity and 12-month post-last dose safety and immune persistence data are presented.

Methods

In this phase III, 1:1 randomized, observer-blind, multicenter trial, patients received 2 doses of RZV or placebo. gE-specific immune responses were assessed at 1 (M2) and 12 (M13) months post-dose 2: humoral immunity by vaccine response rate (VRR) and geometric mean antibody concentration (GMC), and cell-mediated immunity (CMI) by VRR and CD4+ T-cell frequency. Solicited general and unsolicited adverse events (AEs) were collected 7 days pre-dose 1 as a within-participant control. Solicited and unsolicited AEs were also recorded for 7 and 30 days after each dose, respectively. Serious AEs (SAE) and potential immune-mediated diseases (pIMDs) were recorded up to study end (M13).

Results

Humoral and CMI in the RZV group persisted through M13 appearing higher in the RZV group vs. placebo (Table 1). The frequency of solicited local AEs and of general AEs myalgia and fever was higher in the RZV group vs. placebo and balanced between study groups for the other general AEs, pIMDs and SAEs (including allograft rejections) (Table 2, Figure 1). No concerns regarding renal function were reported. Suspected HZ cases were recorded among 2 RZV and 6 placebo recipients. In the RZV group, within-participant pre- and post-vaccination solicited general AEs were reported at similar rates for fatigue, gastrointestinal symptoms and headache, and higher rates post-vaccination for myalgia, shivering, and fever (Figure 1).

Conclusion

RZV was highly immunogenic, eliciting robust humoral and CMI that persisted up to 12 months in adult renal transplant recipients. No safety concerns were identified over a 1-year follow-up.

Reference

1. de la Serna, BMT Tandem Meeting 2018, abs LBA2.

Funding: GlaxoSmithKline Biologicals SA

Disclosures

P. Vink, GSK group of companies: Employee and Shareholder, Salary and stock shares. S. J. Kim, GSK group of companies: Investigator, Research grant and Research support. M. Campins Marti, GSK group of companies: Consultant, Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Research grant and Speaker honorarium. D. Kumar, GSK group of companies: Scientific Advisor, Consulting fee. K. Doucette, GSK group of companies: Investigator, Research support. S. A. McNeil, GSK group of companies: Grant Investigator, Research grant and Research support. L. Campora, GSK group of companies: Employee and Shareholder, Salary. E. Di Paolo, GSK group of companies: Employee, Salary. M. El Idrissi, GSK group of companies: Employee, Salary. M. López-Fauqued, GSK group of companies: Employee, Salary. B. Salaun, GSK group of companies: Employee and Shareholder, Salary. T. Heineman, GSK group of companies: Consultant, Employee and Shareholder, Consulting fee and Salary. L. Oostvogels, GSK group of companies: Employee, Salary and stock and stock option.

Details

Title
2483. Twelve-Month Immunogenicity and Safety of an Adjuvanted Recombinant Zoster Vaccine in Immunosuppressed Adults Post Renal Transplant: a Phase III Randomized Clinical Trial
Author
Vink, Peter 1 ; Josep Maria Ramon Torrell 2 ; Sanchez-Fructuoso, Ana I 3 ; Sung-Joo, Kim 4 ; Sang Il Kim 5 ; Zaltzman, Jeffrey 6 ; Ortiz, Fernanda 7 ; Josep Maria Campistol Plana 8 ; Fernandez Rodriguez, Ana Maria 9 ; Henar Rebollo Rodrigo 10 ; Magda Campins Marti 11 ; Perez, Rafael 12 ; González-Roncero, Francisco Manuel 13 ; Kumar, Deepali 14 ; Yang-Jen, Chiang 15 ; Doucette, Karen 16 ; Pipeleers, Lissa 17 ; Agüera Morales, Maria Luisa 18 ; Rodriguez Ferrero, Maria Luisa 19 ; Secchi, Antonio 20 ; McNeil, Shelly A 21 ; Campora, Laura 22 ; Emmanuel Di Paolo 23 ; Mohamed El Idrissi 23 ; López-Fauqued, Marta 22 ; Salaun, Bruno 23 ; Heineman, Thomas 24 ; Oostvogels, Lidia 1 

 GSK, Rockville, Maryland 
 Bellvitge University Hospital, Barcelona, Spain 
 Hospital Clínico San Carlos, Madrid, Spain 
 Sungkyunkwan University, Seoul, Korea, Republic of (South) 
 Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea, Republic of (South) 
 St. Michael’s University of Toronto, Toronto, ON, Canada 
 Helsinki University Hospital, Helsinki, Finland 
 Hospital Clínic de Barcelona, Barcelona, Spain 
 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  Transplant Infectious Diseases, 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  Scientific Institute San Raffaele, Milan, Italy 
21  Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada 
22  GSK, Wavre, Belgium 
23  GSK, Rixensart, Belgium 
24  GSK, King of Prussia, Pennsylvania; GSK, King of Prussia, PA, Current affiliation: Halozyme Therapeutics, San Diego, California 
Pages
S744-S745
Publication year
2018
Publication date
Nov 2018
Publisher
Oxford University Press
e-ISSN
23288957
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3171027276
Copyright
© The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.