Immunogenicity and safety of a new live attenuated herpes zoster vaccine (NBP608)compared to Zostavax® in healthy adults aged 50 years and older

Wonseok Choi, Jung Hyun Choi, Dong Sik Jung, Hee Jung Choi, Yeon Sook Kim, Jacob Lee, Hee Chang Jang, Eui Cheol Shin, Jun Sik Park, Hun Kim, Hee-Jin Cheong

Research output: Contribution to journalArticle

Abstract

A multi-centre, randomised, double-blinded, active-controlled, parallel-group clinical trial was carried out to assess the immunogenicity and safety of NBP608—a newly developed live-attenuated zoster vaccine in Korea—relative to Zostavax® in healthy adults aged 50 years or older. Immune responses to the vaccine were evaluated by glycoprotein enzyme-linked immunosorbent assay (gpELISA)and enzyme-linked immunosorbent spot (ELISPOT)assays using the interferon (IFN)-γ and interleukin (IL)-2 FluoroSpot kit 6 weeks after vaccination. Safety was monitored for 26 weeks based on subjects’ diaries, spontaneous reports from subjects, and history taking by the investigators. A total of 845 subjects participated in the screening, and 823 received the vaccination (413 in the NBP608 group and 411 in the comparator group). The gpELISA-determined geometric mean fold rise from baseline to post NBP608 vaccination was 2.75 [95% confidence interval, CI (2.57, 2.94)]. The gpELISA-determined adjusted geometric mean titers (GMTs)of NBP608 and the comparator were 1346.37 [95% CI (1273.99, 1422.87)]and 1674.94 [95% CI (1585.35, 1769.58)], respectively. The adjusted GMT ratio of NBP608 to the comparator was 0.80 [95% CI (0.75, 0.87)]. There was no statistically significant difference between two groups in terms of the geometric mean spot numbers determined by IFN-γ and IL-2 ELISPOT assays at 6 weeks post vaccination (P = 0.7232, 0.3844). The incidence of adverse events (AEs)within 6 weeks post vaccination was 49.82% overall (410/823, 941 cases), 50.73% (209/412, 474 cases)in the NBP608 group, and 48.91% (201/411, 467 cases)in the comparator group. The difference in AE rate between the two groups was not statistically significant (P = 0.6010). Most AEs were mild, with a rate of 83.12% in the NBP608 group and 75.37% in the comparator group. Thus, NBP608 is non-inferior to Zostavax® in terms of inducing the immune response and can be safely administered to adults aged 50 years or older. ClinicalTrials.gov Identifier: NCT03120364.

Original languageEnglish
JournalVaccine
DOIs
Publication statusPublished - 2019 Jan 1

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Herpes Zoster Vaccine
Vaccination
Enzyme-Linked Immunosorbent Assay
vaccination
immune response
vaccines
Safety
glycoproteins
Glycoproteins
enzyme-linked immunosorbent assay
interferons
interleukin-2
Interferons
Interleukin-2
Attenuated Vaccines
assays
enzymes
confidence interval
clinical trials
Vaccines

Keywords

  • Attenuated vaccine
  • Clinical trial
  • Herpes zoster vaccine
  • Immunogenicity
  • Prevention of herpes zoster
  • Safety

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Immunogenicity and safety of a new live attenuated herpes zoster vaccine (NBP608)compared to Zostavax® in healthy adults aged 50 years and older. / Choi, Wonseok; Choi, Jung Hyun; Jung, Dong Sik; Choi, Hee Jung; Kim, Yeon Sook; Lee, Jacob; Jang, Hee Chang; Shin, Eui Cheol; Park, Jun Sik; Kim, Hun; Cheong, Hee-Jin.

In: Vaccine, 01.01.2019.

Research output: Contribution to journalArticle

Choi, Wonseok ; Choi, Jung Hyun ; Jung, Dong Sik ; Choi, Hee Jung ; Kim, Yeon Sook ; Lee, Jacob ; Jang, Hee Chang ; Shin, Eui Cheol ; Park, Jun Sik ; Kim, Hun ; Cheong, Hee-Jin. / Immunogenicity and safety of a new live attenuated herpes zoster vaccine (NBP608)compared to Zostavax® in healthy adults aged 50 years and older. In: Vaccine. 2019.
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abstract = "A multi-centre, randomised, double-blinded, active-controlled, parallel-group clinical trial was carried out to assess the immunogenicity and safety of NBP608—a newly developed live-attenuated zoster vaccine in Korea—relative to Zostavax{\circledR} in healthy adults aged 50 years or older. Immune responses to the vaccine were evaluated by glycoprotein enzyme-linked immunosorbent assay (gpELISA)and enzyme-linked immunosorbent spot (ELISPOT)assays using the interferon (IFN)-γ and interleukin (IL)-2 FluoroSpot kit 6 weeks after vaccination. Safety was monitored for 26 weeks based on subjects’ diaries, spontaneous reports from subjects, and history taking by the investigators. A total of 845 subjects participated in the screening, and 823 received the vaccination (413 in the NBP608 group and 411 in the comparator group). The gpELISA-determined geometric mean fold rise from baseline to post NBP608 vaccination was 2.75 [95{\%} confidence interval, CI (2.57, 2.94)]. The gpELISA-determined adjusted geometric mean titers (GMTs)of NBP608 and the comparator were 1346.37 [95{\%} CI (1273.99, 1422.87)]and 1674.94 [95{\%} CI (1585.35, 1769.58)], respectively. The adjusted GMT ratio of NBP608 to the comparator was 0.80 [95{\%} CI (0.75, 0.87)]. There was no statistically significant difference between two groups in terms of the geometric mean spot numbers determined by IFN-γ and IL-2 ELISPOT assays at 6 weeks post vaccination (P = 0.7232, 0.3844). The incidence of adverse events (AEs)within 6 weeks post vaccination was 49.82{\%} overall (410/823, 941 cases), 50.73{\%} (209/412, 474 cases)in the NBP608 group, and 48.91{\%} (201/411, 467 cases)in the comparator group. The difference in AE rate between the two groups was not statistically significant (P = 0.6010). Most AEs were mild, with a rate of 83.12{\%} in the NBP608 group and 75.37{\%} in the comparator group. Thus, NBP608 is non-inferior to Zostavax{\circledR} in terms of inducing the immune response and can be safely administered to adults aged 50 years or older. ClinicalTrials.gov Identifier: NCT03120364.",
keywords = "Attenuated vaccine, Clinical trial, Herpes zoster vaccine, Immunogenicity, Prevention of herpes zoster, Safety",
author = "Wonseok Choi and Choi, {Jung Hyun} and Jung, {Dong Sik} and Choi, {Hee Jung} and Kim, {Yeon Sook} and Jacob Lee and Jang, {Hee Chang} and Shin, {Eui Cheol} and Park, {Jun Sik} and Hun Kim and Hee-Jin Cheong",
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AU - Choi, Wonseok

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AU - Jung, Dong Sik

AU - Choi, Hee Jung

AU - Kim, Yeon Sook

AU - Lee, Jacob

AU - Jang, Hee Chang

AU - Shin, Eui Cheol

AU - Park, Jun Sik

AU - Kim, Hun

AU - Cheong, Hee-Jin

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N2 - A multi-centre, randomised, double-blinded, active-controlled, parallel-group clinical trial was carried out to assess the immunogenicity and safety of NBP608—a newly developed live-attenuated zoster vaccine in Korea—relative to Zostavax® in healthy adults aged 50 years or older. Immune responses to the vaccine were evaluated by glycoprotein enzyme-linked immunosorbent assay (gpELISA)and enzyme-linked immunosorbent spot (ELISPOT)assays using the interferon (IFN)-γ and interleukin (IL)-2 FluoroSpot kit 6 weeks after vaccination. Safety was monitored for 26 weeks based on subjects’ diaries, spontaneous reports from subjects, and history taking by the investigators. A total of 845 subjects participated in the screening, and 823 received the vaccination (413 in the NBP608 group and 411 in the comparator group). The gpELISA-determined geometric mean fold rise from baseline to post NBP608 vaccination was 2.75 [95% confidence interval, CI (2.57, 2.94)]. The gpELISA-determined adjusted geometric mean titers (GMTs)of NBP608 and the comparator were 1346.37 [95% CI (1273.99, 1422.87)]and 1674.94 [95% CI (1585.35, 1769.58)], respectively. The adjusted GMT ratio of NBP608 to the comparator was 0.80 [95% CI (0.75, 0.87)]. There was no statistically significant difference between two groups in terms of the geometric mean spot numbers determined by IFN-γ and IL-2 ELISPOT assays at 6 weeks post vaccination (P = 0.7232, 0.3844). The incidence of adverse events (AEs)within 6 weeks post vaccination was 49.82% overall (410/823, 941 cases), 50.73% (209/412, 474 cases)in the NBP608 group, and 48.91% (201/411, 467 cases)in the comparator group. The difference in AE rate between the two groups was not statistically significant (P = 0.6010). Most AEs were mild, with a rate of 83.12% in the NBP608 group and 75.37% in the comparator group. Thus, NBP608 is non-inferior to Zostavax® in terms of inducing the immune response and can be safely administered to adults aged 50 years or older. ClinicalTrials.gov Identifier: NCT03120364.

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KW - Clinical trial

KW - Herpes zoster vaccine

KW - Immunogenicity

KW - Prevention of herpes zoster

KW - Safety

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