Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 최희정 | * |
dc.date.accessioned | 2019-07-22T16:30:11Z | - |
dc.date.available | 2019-07-22T16:30:11Z | - |
dc.date.issued | 2019 | * |
dc.identifier.issn | 0264-410X | * |
dc.identifier.issn | 1873-2518 | * |
dc.identifier.other | OAK-25057 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/250075 | - |
dc.description.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 (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. | * |
dc.language | English | * |
dc.publisher | ELSEVIER SCI LTD | * |
dc.subject | Herpes zoster vaccine | * |
dc.subject | Prevention of herpes zoster | * |
dc.subject | Attenuated vaccine | * |
dc.subject | Immunogenicity | * |
dc.subject | Safety | * |
dc.subject | Clinical trial | * |
dc.title | Immunogenicity and safety of a new live attenuated herpes zoster vaccine (NBP608) compared to Zostavax (R) in healthy adults aged 50 years and older | * |
dc.type | Article | * |
dc.relation.issue | 27 | * |
dc.relation.volume | 37 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.startpage | 3605 | * |
dc.relation.lastpage | 3610 | * |
dc.relation.journaltitle | VACCINE | * |
dc.identifier.doi | 10.1016/j.vaccine.2019.04.046 | * |
dc.identifier.wosid | WOS:000474325600013 | * |
dc.author.google | Choi, Won Suk | * |
dc.author.google | Choi, Jung Hyun | * |
dc.author.google | Jung, Dong Sik | * |
dc.author.google | Choi, Hee Jung | * |
dc.author.google | Kim, Yeon-Sook | * |
dc.author.google | Lee, Jacob | * |
dc.author.google | Jang, Hee-Chang | * |
dc.author.google | Shin, Eui-Cheol | * |
dc.author.google | Park, Jun-Sik | * |
dc.author.google | Kim, Hun | * |
dc.author.google | Cheong, Hee Jin A. | * |
dc.contributor.scopusid | 최희정(57217262202) | * |
dc.date.modifydate | 20240422112010 | * |