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

Won Suk 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

doi:10.1016/j.vaccine.2019.04.046

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

Won Suk 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

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

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 language	English
Pages (from-to)	3605-3610
Number of pages	6
Journal	Vaccine
Volume	37
Issue number	27
DOIs	https://doi.org/10.1016/j.vaccine.2019.04.046
State	Published - 12 Jun 2019

Bibliographical note

Funding Information:
This study was supported by SK bioscience Co., Ltd. The study was designed, executed, and analysed by the sponsor. Although the sponsor reviewed a draft of the manuscript, the opinions expressed in this article do not necessarily reflect those of the sponsor.

Publisher Copyright:
© 2019

Keywords

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.vaccine.2019.04.046

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@article{00415a7b5c174acfb78945e9e53d0a8f,

title = "Immunogenicity and safety of a new live attenuated herpes zoster vaccine (NBP608) compared to Zostavax{\textregistered} in healthy adults aged 50 years and older",

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{\textregistered} 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{\textquoteright} 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{\textregistered} 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 = "Choi, {Won Suk} 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 Cheong, {Hee Jin}",

note = "Funding Information: This study was supported by SK bioscience Co., Ltd. The study was designed, executed, and analysed by the sponsor. Although the sponsor reviewed a draft of the manuscript, the opinions expressed in this article do not necessarily reflect those of the sponsor. Publisher Copyright: {\textcopyright} 2019",

year = "2019",

month = jun,

day = "12",

doi = "10.1016/j.vaccine.2019.04.046",

language = "English",

volume = "37",

pages = "3605--3610",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier BV",

number = "27",

}

TY - JOUR

T1 - Immunogenicity and safety of a new live attenuated herpes zoster vaccine (NBP608) compared to Zostavax® in healthy adults aged 50 years and older

AU - Choi, Won Suk

AU - Choi, Jung Hyun

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

N1 - Funding Information: This study was supported by SK bioscience Co., Ltd. The study was designed, executed, and analysed by the sponsor. Although the sponsor reviewed a draft of the manuscript, the opinions expressed in this article do not necessarily reflect those of the sponsor. Publisher Copyright: © 2019

PY - 2019/6/12

Y1 - 2019/6/12

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.

AB - 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.

KW - Attenuated vaccine

KW - Clinical trial

KW - Herpes zoster vaccine

KW - Immunogenicity

KW - Prevention of herpes zoster

KW - Safety

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DO - 10.1016/j.vaccine.2019.04.046

M3 - Article

C2 - 31122860

AN - SCOPUS:85065763539

SN - 0264-410X

VL - 37

SP - 3605

EP - 3610

JO - Vaccine

JF - Vaccine

IS - 27

ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

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