Immunogenicity and safety of a new live attenuated herpes zoster vaccine (NBP608) compared to Zostavax (R) in healthy adults aged 50 years and older
- 주제(키워드) Herpes zoster vaccine , Prevention of herpes zoster , Attenuated vaccine , Immunogenicity , Safety , Clinical trial
- 주제(기타) Immunology; Medicine, Research & Experimental
- 설명문(일반) [Choi, Won Suk; Cheong, Hee Jin A.] Korea Univ, Dept Internal Med, Div Infect Dis, Coll Med, Seoul, South Korea; [Choi, Jung Hyun] Catholic Univ Korea, Incheon St Marys Hosp, Dept Internal Med, Div Infect Dis, Incheon, South Korea; [Jung, Dong Sik] Dong A Univ Hosp, Dept Internal Med, Div Infect Dis, Busan, South Korea; [Choi, Hee Jung] Ewha Womans Univ, Dept Internal Med, Div Infect Dis, Mokdong Hosp, Seoul, South Korea; [Kim, Yeon-Sook] Chungnam Natl Univ, Dept Internal Med, Div Infect Dis, Sch Med, Daejon, South Korea; [Lee, Jacob] Hallym Univ, Dept Internal Med, Div Infect Dis, Coll Med, Chunchon, South Korea; [Jang, Hee-Chang] Chonnam Natl Univ, Dept Infect Dis, Med Sch, Gwangju, South Korea; [Shin, Eui-Cheol; Park, Jun-Sik] Korea Adv Inst Sci & Technol, Lab Immunol & Infect Dis, Grad Sch Med Sci & Engn, Daejeon, South Korea; [Kim, Hun] SK Biosci, Life Sci Res Inst, Seongnam, Gyeonggi Do, South Korea
- 등재 SCIE, SCOPUS
- 발행기관 ELSEVIER SCI LTD
- 발행년도 2019
- URI http://www.dcollection.net/handler/ewha/000000159897
- 본문언어 영어
- Published As http://dx.doi.org/10.1016/j.vaccine.2019.04.046
- PubMed https://pubmed.ncbi.nlm.nih.gov/31122860
초록/요약
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 (R) 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)-gamma 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-gamma 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 (R) in terms of inducing the immune response and can be safely administered to adults aged 50 years or older. (C) 2019 Published by Elsevier Ltd.
more