PMID- 34931494
OWN - NLM
STAT- MEDLINE
DCOM- 20220309
LR  - 20220309
IS  - 1598-6357 (Electronic)
IS  - 1011-8934 (Print)
IS  - 1011-8934 (Linking)
VI  - 36
IP  - 49
DP  - 2021 Dec 20
TI  - Immunogenicity and Safety of a Newly Developed Tetanus-Diphtheria Toxoid (Td) in 
      Healthy Korean Adolescents: a Multi-center, Randomized, Double-blind, 
      Active-Controlled Phase 3 Trial.
PG  - e313
LID - 10.3346/jkms.2021.36.e313 [doi]
LID - e313
AB  - 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. TRIAL 
      REGISTRATION: ClinicalTrials.gov Identifier: NCT04618939.
CI  - (c) 2021 The Korean Academy of Medical Sciences.
FAU - Choi, Ui Yoon
AU  - Choi UY
AUID- ORCID: 0000-0002-7190-8812
AD  - Department of Pediatrics, Eunpyeong St. Mary's Hospital, College of Medicine, The 
      Catholic University of Korea, Seoul, Korea.
FAU - Kim, Ki Hwan
AU  - Kim KH
AUID- ORCID: 0000-0001-6145-3909
AD  - Department of Pediatrics, Incheon St. Mary's Hospital, College of Medicine, The 
      Catholic University of Korea, Seoul, Korea.
FAU - Lee, Jin
AU  - Lee J
AUID- ORCID: 0000-0002-6039-2224
AD  - Department of Pediatrics, Hanil General Hospital, Seoul, Korea.
FAU - Eun, Byung Wook
AU  - Eun BW
AUID- ORCID: 0000-0003-3147-9061
AD  - Department of Pediatrics, Nowon Eulji University Hospital, Eulji University 
      School of Medicine, Seoul, Korea.
FAU - Kim, Hwang Min
AU  - Kim HM
AUID- ORCID: 0000-0002-0329-1371
AD  - Department of Pediatrics, Wonju Severance Christian Hospital, Yonsei University 
      Wonju College of Medicine, Wonju, Korea.
FAU - Lee, Kyung-Yil
AU  - Lee KY
AUID- ORCID: 0000-0001-6510-1580
AD  - Department of Pediatrics, Daejeon St. Mary's Hospital, College of Medicine, The 
      Catholic University of Korea, Seoul, Korea.
FAU - Kim, Dong Ho
AU  - Kim DH
AUID- ORCID: 0000-0001-6440-6956
AD  - Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Korea.
FAU - Ma, Sang Hyuk
AU  - Ma SH
AUID- ORCID: 0000-0002-4835-9704
AD  - Department of Pediatrics, Changwon Fatima Hospital, Changwon, Korea.
FAU - Lee, Jina
AU  - Lee J
AUID- ORCID: 0000-0002-3435-251X
AD  - Department of Pediatrics, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Kim, Jong-Hyun
AU  - Kim JH
AUID- ORCID: 0000-0001-8641-7904
AD  - Department of Pediatrics, St. Vincent's Hospital, College of Medicine, The 
      Catholic University of Korea, Seoul, Korea. jh00mn@catholic.ac.kr.
LA  - eng
SI  - ClinicalTrials.gov/NCT04618939
GR  - Boryung Biopharma Co., Ltd/Korea
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20211220
PL  - Korea (South)
TA  - J Korean Med Sci
JT  - Journal of Korean medical science
JID - 8703518
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Diphtheria-Tetanus Vaccine)
SB  - IM
MH  - Antibodies, Bacterial/blood
MH  - Antibody Formation
MH  - Child
MH  - Diphtheria/immunology/*prevention & control
MH  - Diphtheria-Tetanus Vaccine/administration & dosage/adverse effects/*immunology
MH  - Double-Blind Method
MH  - Enzyme-Linked Immunosorbent Assay
MH  - Erythema/etiology
MH  - Female
MH  - Humans
MH  - Male
MH  - Pain/etiology/pathology
MH  - Republic of Korea
MH  - Tetanus/immunology/*prevention & control
PMC - PMC8688341
OTO - NOTNLM
OT  - Clinical Trial
OT  - Diphtheria Toxoid
OT  - Immunity
OT  - Safety
OT  - Tetanus Toxoid
COIS- The authors have no potential conflicts of interest to disclose.
EDAT- 2021/12/22 06:00
MHDA- 2022/03/11 06:00
PMCR- 2021/12/20
CRDT- 2021/12/21 07:06
PHST- 2021/08/23 00:00 [received]
PHST- 2021/10/20 00:00 [accepted]
PHST- 2021/12/21 07:06 [entrez]
PHST- 2021/12/22 06:00 [pubmed]
PHST- 2022/03/11 06:00 [medline]
PHST- 2021/12/20 00:00 [pmc-release]
AID - 36.e313 [pii]
AID - 10.3346/jkms.2021.36.e313 [doi]
PST - epublish
SO  - J Korean Med Sci. 2021 Dec 20;36(49):e313. doi: 10.3346/jkms.2021.36.e313.