J Korean Med Sci.  2016 Jan;31(1):13-17. 10.3346/jkms.2016.31.1.13.

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

Affiliations
  • 1Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. heejinmd@korea.ac.kr
  • 2Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
  • 3Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
  • 4Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
  • 5Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
  • 6Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Abstract

A live attenuated zoster vaccine (ZOSTAVAX(TM), 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 > or =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 > or =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 > or =1 systemic AE, 10 (5.5%) subjects experienced a systemic vaccine-related AE, and 3 (1.7%) subjects experienced > or =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 > or =50 yr of age (registry at www.clinicaltrial.gov No. NCT01556451).

Keyword

Immunology; Adverse Effects; Aged; Herpes Zoster Vaccine; Humans; Republic of Korea

MeSH Terms

Aged
Antibodies, Viral/blood
Enzyme-Linked Immunosorbent Assay
Erythema/etiology
Female
Herpes Zoster/*prevention & control
Herpes Zoster Vaccine/adverse effects/*immunology
Herpesvirus 3, Human/immunology
Humans
Male
Middle Aged
Antibodies, Viral
Herpes Zoster Vaccine
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