Safety and immunogenicity of an AS01-adjuvanted varicella zoster virus subunit candidate vaccine (HZ/su)

Abstract

An adjuvanted recombinant subunit candidate vaccine (HZ/su) containing varicella zoster virus envelope glycoprotein E was developed for the prevention of herpes zoster and its complications. This study evaluated safety and reactogenicity of HZ/su in an ethnic Japanese population. This was a phase I, open-label and single-center study conducted between March and November of 2010 in Australia. Twenty healthy ethnic Japanese subjects, aged 18–30 y and 50–69 y (1:1) were enrolled. Subjects were administered two doses of HZ/su vaccine according to a 0, 2-mo schedule. Local and general solicited symptoms were recorded for 7 d post-vaccination. Unsolicited symptoms were recorded for 30 d post-vaccination. Serious adverse events (SAEs), new onset of autoimmune disease (NOAD), other potential immune mediated disorders and HZ cases were recorded throughout the study period. All 20 subjects were included in the according-to-protocol cohort for safety. A total of 18 subjects were included in the according-to-protocol cohort for immunogenicity: 10 in the 18–30 y age group and 8 in the 50–69 y age group. The most commonly reported local and general solicited symptoms were pain and fatigue in both groups. Back pain (in the 18–30 y age group) and chills (in the 50–69 y age group) were the most frequently reported unsolicited symptoms. There were no reports of death, SAEs, NOADs, other autoimmune mediated inflammatory disorder or suspected HZ cases. This study indicated that the two-dose regimen of HZ/su exhibited a clinically acceptable safety profile in healthy young and older ethnic Japanese adults.

Keywords: :

• adjuvant
• herpes zoster vaccine
• Japanese
• safety
• reactogenicity
• varicella-zoster virus

Disclosure of Potential Conflicts of Interest

All authors are employed by the GlaxoSmithKline group of companies. Thomas Heineman owns GSK stock and stock options.

Acknowledgments

This study (eTrack: 113819/NCT01086449) was sponsored and funded by GlaxoSmithKline Biologicals SA, Belgium. GlaxoSmithKline Biologicals SA also took charge of all costs associated with the development and publishing of the manuscript. The authors thank Jennifer Yuan for carrying out the clinical trial, Ashmita Ravishankar for medical writing and Jarno Jansen for editorial assistance and coordination in the preparation of this manuscript.