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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.
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Details
1 GSK, Rockville, Maryland
2 Bellvitge University Hospital, Barcelona, Spain
3 Hospital Clínico San Carlos, Madrid, Spain
4 Sungkyunkwan University, Seoul, Korea, Republic of (South)
5 Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea, Republic of (South)
6 St. Michael’s University of Toronto, Toronto, ON, Canada
7 Helsinki University Hospital, Helsinki, Finland
8 Hospital Clínic de Barcelona, 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 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