Immunogenicity and safety of a live attenuated zoster vaccine (ZOSTAVAX™) in Korean adults

Won Suk Choi, Jung Hyun Choi, JunYong Choi, Joong Sik Eom, Sang Il Kim, Hyunjoo Pai, Kyong Ran Peck, Jang Wook Sohn, Hee Jin Cheong

Research output: Contribution to journalArticle

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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 postvaccination, 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).

Original languageEnglish
Pages (from-to)13-17
Number of pages5
JournalJournal of Korean medical science
Volume31
Issue number1
DOIs
Publication statusPublished - 2016 Jan 1

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Herpes Zoster Vaccine
Attenuated Vaccines
Human Herpesvirus 3
Chickenpox
Herpes Zoster
Exanthema
Safety
Glycoproteins
Vaccination
Vaccines
Enzyme-Linked Immunosorbent Assay
Population
Injections
Food Safety
Erythema
Korea
Antibody Formation
Registries
Antibodies
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Choi, Won Suk ; Choi, Jung Hyun ; Choi, JunYong ; Eom, Joong Sik ; Kim, Sang Il ; Pai, Hyunjoo ; Peck, Kyong Ran ; Sohn, Jang Wook ; Cheong, Hee Jin. / Immunogenicity and safety of a live attenuated zoster vaccine (ZOSTAVAX™) in Korean adults. In: Journal of Korean medical science. 2016 ; Vol. 31, No. 1. pp. 13-17.
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author = "Choi, {Won Suk} and Choi, {Jung Hyun} and JunYong Choi and Eom, {Joong Sik} and Kim, {Sang Il} and Hyunjoo Pai and Peck, {Kyong Ran} and Sohn, {Jang Wook} and Cheong, {Hee Jin}",
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Choi, WS, Choi, JH, Choi, J, Eom, JS, Kim, SI, Pai, H, Peck, KR, Sohn, JW & Cheong, HJ 2016, 'Immunogenicity and safety of a live attenuated zoster vaccine (ZOSTAVAX™) in Korean adults', Journal of Korean medical science, vol. 31, no. 1, pp. 13-17. https://doi.org/10.3346/jkms.2016.31.1.13

Immunogenicity and safety of a live attenuated zoster vaccine (ZOSTAVAX™) in Korean adults. / Choi, Won Suk; Choi, Jung Hyun; Choi, JunYong; Eom, Joong Sik; Kim, Sang Il; Pai, Hyunjoo; Peck, Kyong Ran; Sohn, Jang Wook; Cheong, Hee Jin.

In: Journal of Korean medical science, Vol. 31, No. 1, 01.01.2016, p. 13-17.

Research output: Contribution to journalArticle

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AU - Choi, Won Suk

AU - Choi, Jung Hyun

AU - Choi, JunYong

AU - Eom, Joong Sik

AU - Kim, Sang Il

AU - Pai, Hyunjoo

AU - Peck, Kyong Ran

AU - Sohn, Jang Wook

AU - Cheong, Hee Jin

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