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Immunogenicity and Safety of a Live Attenuated Zoster Vaccine (ZOSTAVAX™) in Korean Adults

Authors
 Won Suk Choi  ;  Jung-Hyun Choi  ;  Jun Yong Choi  ;  Joong Sik Eom  ;  Sang Il Kim  ;  Hyunjoo Pai  ;  Kyong Ran Peck  ;  Jang Wook Sohn  ;  Hee Jin Cheong 
Citation
 JOURNAL OF KOREAN MEDICAL SCIENCE, Vol.31(1) : 13-17, 2016 
Journal Title
JOURNAL OF KOREAN MEDICAL SCIENCE
ISSN
 1011-8934 
Issue Date
2016
MeSH
Aged ; Antibodies, Viral/blood ; Enzyme-Linked Immunosorbent Assay ; Erythema/etiology ; Female ; Herpes Zoster/prevention & control* ; Herpes Zoster Vaccine/adverse effects ; Herpes Zoster Vaccine/immunology* ; Herpesvirus 3, Human/immunology ; Humans ; Male ; Middle Aged
Keywords
Adverse Effects ; Aged ; Herpes Zoster Vaccine ; Humans ; Immunology ; Republic of Korea
Abstract
A live attenuated zoster vaccine (ZOSTAVAX™, Merck & Co., Inc.) was approved by the Korea Ministry of Food and Drug Safety in 2009. However, the immunogenicity and safety of the vaccine has not been assessed in Korean population. This is multi-center, open-label, single-arm study performed with 180 healthy Korean adults ≥ 50 yr of age. The geometric mean titer (GMT) and geometric mean fold rise (GMFR) of varicella zoster virus (VZV) antibodies were measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) at 4 weeks post-vaccination. Subjects were followed for exposure to varicella or herpes zoster (HZ), the development of any varicella/varicella-like or HZ/HZ-like rashes, and any other clinical adverse experiences (AEs) for 42 days post-vaccination. For the 166 subjects included in the per-protocol population, the GMT at Day 1 was 66.9. At 4 weeks post-vaccination, the GMT for this population was 185.4, with a GMFR of 2.8 (95% CI, 2.5-3.1). Of the 180 subjects vaccinated, 62.8% experienced ≥ 1 AE, with 53.3% of subjects reporting injection-site AEs. The most frequently reported injection-site AEs were erythema (45.0%) with the majority being mild in intensity. Overall, 44 (24.4%) subjects experienced ≥ 1 systemic AE, 10 (5.5%) subjects experienced a systemic vaccine-related AE, and 3 (1.7%) subjects experienced ≥ 1 serious AE not related to vaccine. No subjects reported a VZV-like rash. There was no subject of death and no subject discontinued due to an adverse event. A single dose of zoster vaccine induced VZV-specific gpELISA antibody response and was generally well-tolerated in healthy Korean adults ≥50 yr of age (registry at www.clinicaltrial.gov No. NCT01556451).
Files in This Item:
T201600510.pdf Download
DOI
10.3346/jkms.2016.31.1.13
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Choi, Jun Yong(최준용) ORCID logo https://orcid.org/0000-0002-2775-3315
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/146439
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