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논문 기본 정보

자료유형
학술저널
저자정보
Choi Ui Yoon (Department of Pediatrics Eunpyeong St. Mary's Hospital College of Medicine The Catholic University) Kim Ki Hwan (Department of Pediatrics Incheon St. Mary's Hospital College of Medicine The Catholic University of) Lee Jin (Department of Pediatrics Hanil General Hospital Seoul Korea.) Eun Byung Wook (Department of Pediatrics Nowon Eulji University Hospital Eulji University School of Medicine Seoul) Kim Hwang Min (Department of Pediatrics Wonju Severance Christian Hospital Yonsei University Wonju College of Medi) Lee Kyung-Yil (Department of Pediatrics Daejeon St. Mary's Hospital College of Medicine The Catholic University of) Kim Dong Ho (Department of Pediatrics Korea Cancer Center Hospital Seoul Korea.) Ma Sang Hyuk (Department of Pediatrics Changwon Fatima Hospital Changwon Korea.) Lee Jina (Department of Pediatrics Asan Medical Center University of Ulsan College of Medicine Seoul Korea.) Kim Jong-Hyun (Department of Pediatrics St. Vincent's Hospital College of Medicine The Catholic University of Kore)
저널정보
대한의학회 Journal of Korean Medical Science Journal of Korean Medical Science Vol.36 No.49
발행연도
2021.12
수록면
1 - 11 (11page)
DOI
10.3346/jkms.2021.36.e313

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Background: Although the combination tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) is recommended at adolescence in developed countries, the tetanus and diphtheria toxoid vaccine (Td), which is less costly, is recommended instead in some parts of the world. A new Td, BR-TD-1001, was developed by a Korean manufacturer for distribution to endemic regions and for use in the initial step of novel Tdap development. Methods: This phase 3, randomized, double-blind, multi-center trial, conducted in Korea, aimed to evaluate the immunogenicity and safety of BR-TD-1001. Healthy children aged 10 to 12 years were randomized 1:1 to receive either BR-TD-1001 or the control Td (Td-pur, GlaxoSmithKline). Antibodies were measured using enzyme-linked immunosorbent assay. Results: A total of 218 subjects (BR-TD-1001, n = 108; control, n = 110) were enrolled and included in the safety analysis. Vaccine-mediated antibody responses were similar in both groups. We confirmed the non-inferiority of BR-TD-1001 against the control, Td; 100% of both groups achieved seroprotection against diphtheria and tetanus. Furthermore, there was no significant difference between groups in the proportion of participants who demonstrated boost responses against diphtheria and tetanus toxoids. The incidence of solicited local and systemic adverse events (AEs), unsolicited AEs, and serious AEs did not differ significantly between groups. Conclusion: The BR-TD-1001 satisfied the immunological non-inferiority criterion against diphtheria and tetanus, with a clinically acceptable safety profile.
#Tetanus Toxoid #Diphtheria Toxoid #Immunity #Safety #Clinical Trial

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참고문헌 (29)

참고문헌 신청
김정헌 / 2018 / An Urgent Need for Global Preparedness against the Reemergence of “Forgotten” Infectious Diseases in Korea / Journal of Korean Medical Science 33(17):19~21 dbpia Mungall BA / 2021 / A systematic review of the burden of pertussis in South Korea / Hum Vaccin Immunother 17(6):1747~1756 google schola Clarke KE / 2019 / Global epidemiology of diphtheria, 2000–2017 / Emerg Infect Dis 25(10):1834~1842 google schola Our World Data / Tetanus google schola 유석현 / 2018 / Outbreak investigation of pertussis in an elementary school: a case-control study among vaccinated students / Clinical and Experimental Vaccine Research 7(1):70~75 dbpia

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