title: Immunogenicity and Safety of a Live Attenuated Zoster Vaccine (ZOSTAVAX™) in Korean Adults.
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).
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
authors.forename: Won Suk
authors.identifier: 0000-0001-5874-4764
authors.initials: WS
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Jung-Hyun
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Jun Yong
authors.identifier: 0000-0002-2775-3315
authors.initials: JY
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Joong Sik
authors.initials: JS
authors.lastname: Eom
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Sang Il
authors.initials: SI
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
authors.forename: Hyunjoo
authors.identifier: 0000-0003-4143-035X
authors.initials: H
authors.lastname: Pai
authors.affiliation: Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Kyong Ran
authors.identifier: 0000-0002-7464-9780
authors.initials: KR
authors.lastname: Peck
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
authors.forename: Jang Wook
authors.initials: JW
authors.lastname: Sohn
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
authors.forename: Hee Jin
authors.identifier: 0000-0002-2532-1463
authors.initials: HJ
authors.lastname: Cheong
mesh_terms: D000368:Aged; D000914:Antibodies, Viral / Q000097:blood; D004797:Enzyme-Linked Immunosorbent Assay; D004890:Erythema / Q000209:etiology; D005260:Female; D006562:Herpes Zoster / Q000517:prevention & control*; D053061:Herpes Zoster Vaccine / Q000009:adverse effects / Q000276:immunology*; D014645:Herpesvirus 3, Human / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D000914:Antibodies, Viral; D053061:Herpes Zoster Vaccine
keywords: Adverse Effects; Aged; Herpes Zoster Vaccine; Humans; Immunology; Republic of Korea