The immunogenicity and safety of zoster vaccine in Taiwanese adults

Abstract

The efficacy and safety of ZOSTAVAX in subjects 60 years of age and older was established in the Shingles Prevention Study (SPS) and in subjects 50 to 59 years of age in the ZOSTAVAX Efficacy and Safety Trial (ZEST). We evaluated the safety and immunogenicity of ZOSTAVAX in a total of 150 Taiwanese subjects ≥50 years of age, who received a single dose of ZOSTAVAX. gpELISA was used to determine geometric mean titers (GMT) of the varicella-zoster virus (VZV) antibody. The geometric mean fold rise (GMFR) of the VZV antibody from the pre-vaccination to the 4 week post-vaccination time point was calculated. There was an overall increase in GMT from 128.45 to 391.85 at 4 weeks post-vaccination. The estimated GMFR was 3.05 (95% CI: 2.60 to 3.57).There were no serious adverse events for 28 days following vaccination. This study demonstrated the safety and immunogenicity of ZOSTAVAX among healthy Taiwanese adults.

Keywords: Geometric mean fold rise; Herpes zoster; Immunogenicity; NCT00444860; Safety; Zoster vaccine.