Immunogenicity and safety of a novel recombinant protective antigen anthrax vaccine (GC1109), a randomized, single-blind, placebo controlled phase II clinical study
- 주제(키워드) Bacillus anthracis , Recombinant protective antigen anthrax vaccine , Immunogenicity , Safety
- 주제(기타) Immunology
- 주제(기타) Medicine, Research & Experimental
- 설명문(일반) [Kang, Chang Kyung; Kim, Nak-Hyun; Kim, Chung-Jong; Choe, Pyoeng Gyun; Park, Wan Beom; Kim, Nam-Joong; Oh, Myoung-don] Seoul Natl Univ, Coll Med, Dept Internal Med, Seoul, South Korea; [Kang, Chang Kyung; Kim, Nak-Hyun; Kim, Chung-Jong; Choe, Pyoeng Gyun; Park, Wan Beom; Kim, Nam-Joong; Oh, Myoung-don] Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea; [Rhie, Gi-eun; Jo, Su Kyoung] Korea Ctr Dis Control & Prevent, Ctr Lab Control Infect Dis, Div High Risk Pathogens, Chungju, South Korea; [Ahn, Misun; Kang, Jieun] GC Pharma Cent Res Ctr, Yongin, South Korea
- 등재 SCIE, SCOPUS
- 발행기관 ELSEVIER SCI LTD
- 발행년도 2019
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000171997
- 본문언어 영어
- Published As https://dx.doi.org/10.1016/j.vaccine.2019.05.057
초록/요약
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.
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