Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 김충종 | * |
dc.date.accessioned | 2020-08-20T16:30:21Z | - |
dc.date.available | 2020-08-20T16:30:21Z | - |
dc.date.issued | 2019 | * |
dc.identifier.issn | 0264-410X | * |
dc.identifier.issn | 1873-2518 | * |
dc.identifier.other | OAK-27601 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/255048 | - |
dc.description.abstract | Background: The demand on effective and safe anthrax vaccine is increasing as a part of the preparedness for possible bioterrorism in the future. We performed a randomized, single-blind, placebo controlled phase 11 clinical study to evaluate the immunogenicity and safety of a novel recombinant protective antigen (rPA) anthrax vaccine, GC1109, in healthy adult volunteers. Methods: Participants were randomized to experiment groups (0.3 mL, 0.5 mL, and 1.0 mL of GC1109) or placebo group (normal saline 0.5 mL) in 2:2:2:1 ratio. They received respective vaccines intramuscularly at 0, 4 and 8 weeks. Immunogenicity was evaluated by seroconversion rate and geometric mean titer (GMT) of lethal toxin neutralizing assay (TNA) and anti-PA IgG by ELISA. Safety was assessed by laboratory tests, and solicited and unsolicited adverse events on diary cards. Results: 30, 29, 30 participants were randomized to 0.3, 0.5, and 1.0 mL of GC1109 groups, respectively, while 15 to placebo group. 92 participants received all three doses. In per-protocol analysis, TNA GMTs at week 12 were 296.5, 285.2, and 433.2 in the three groups, respectively. Seroconversion rates measured by ELISA were 100% at week 12 in the three groups. Local and systemic vaccine-related adverse events were frequent; however, most of them were mild, and no serious events were observed. Conclusions: A new rPA anthrax vaccine GC1109 was immunogenic after three doses of intramuscular administration, and was well-tolerated. (C) 2019 Elsevier Ltd. All rights reserved. | * |
dc.language | English | * |
dc.publisher | ELSEVIER SCI LTD | * |
dc.subject | Bacillus anthracis | * |
dc.subject | Recombinant protective antigen anthrax vaccine | * |
dc.subject | Immunogenicity | * |
dc.subject | Safety | * |
dc.title | Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study | * |
dc.type | Article | * |
dc.relation.issue | 29 | * |
dc.relation.volume | 37 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.startpage | 3820 | * |
dc.relation.lastpage | 3824 | * |
dc.relation.journaltitle | VACCINE | * |
dc.identifier.doi | 10.1016/j.vaccine.2019.05.057 | * |
dc.identifier.wosid | WOS:000472984900011 | * |
dc.author.google | Kang, Chang Kyung | * |
dc.author.google | Kim, Nak-Hyun | * |
dc.author.google | Kim, Chung-Jong | * |
dc.author.google | Rhie, Gi-eun | * |
dc.author.google | Jo, Su Kyoung | * |
dc.author.google | Ahn, Misun | * |
dc.author.google | Kang, Jieun | * |
dc.author.google | Choe, Pyoeng Gyun | * |
dc.author.google | Park, Wan Beom | * |
dc.author.google | Kim, Nam-Joong | * |
dc.author.google | Oh, Myoung-don | * |
dc.contributor.scopusid | 김충종(45361165100) | * |
dc.date.modifydate | 20240527135444 | * |