title: Safety and immunogenicity of a single intramuscular dose of a tetanus-diphtheria toxoid (Td) vaccine (BR-TD-1001) in healthy Korean adult subjects.
abstract: BR-TD-1001 was developed as a booster for the immunity maintenance of diphtheria and tetanus. The aim of this study was to evaluate the safety and immunogenicity of BR-TD-1001 (test vaccine) in comparison with placebo and an active comparator in healthy Korean adults. A randomized, double-blind, placebo-controlled, active comparator, phase I clinical trial was conducted. Fifty subjects were randomly assigned to one of 3 treatment groups in a ratio of 2:2:1, and were administered a single intramuscular dose of test vaccine, active comparator, or placebo, respectively. All subjects were monitored for 4 weeks after injection. The antibody titers of the patients 2 and 4 weeks after vaccination were compared with the baseline. The frequencies of all adverse events including adverse drug reactions in the test group were not statistically different from those of the other treatment groups (P = 0.4974, 0.3061). No serious adverse event occurred, and no subject was withdrawn from the study for safety. The seroprotection rates against both tetanus and diphtheria at 4 weeks after vaccination were over 0.95. For anti-tetanus antibody, the geometric mean titer in the test group was significantly higher than those of the other groups (P = 0.0364, 0.0033). The geometric mean titer of anti-diphtheria antibody in the test group was significantly higher than the value of the placebo (P = 0.0347) while it was not for the value of the active comparator (P = 0.8484). In conclusion, BR-TD-1001 was safe, well-tolerated, and showed sufficient immunogenicity as a booster for diphtheria and tetanus.
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics ; The Catholic University of Korea Seoul; St. Mary's Hospital ; Seoul , Republic of Korea.
authors.forename: Taegon
authors.initials: T
authors.lastname: Hong
authors.affiliation: b Boryung Biopharma Co., Ltd. ; Seoul , Republic of Korea.|c Department of Biotechnology ; College of Life Sciences and Biotechnology; Korea University ; Seoul , Republic of Korea.
authors.forename: Yong-Ju
authors.initials: YJ
authors.lastname: Chung
authors.affiliation: b Boryung Biopharma Co., Ltd. ; Seoul , Republic of Korea.
authors.forename: Tae-Yeon
authors.initials: TY
authors.lastname: Kim
authors.affiliation: c Department of Biotechnology ; College of Life Sciences and Biotechnology; Korea University ; Seoul , Republic of Korea.
authors.forename: Ik-Hwan
authors.initials: IH
authors.lastname: Kim
authors.affiliation: d Korea Research Institute of Bioscience and Biotechnology ; Daejeon , Republic of Korea.
authors.forename: Yong-Kyung
authors.initials: YK
authors.lastname: Choe
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics ; The Catholic University of Korea Seoul; St. Mary's Hospital ; Seoul , Republic of Korea.
authors.forename: Jongtae
authors.initials: J
authors.lastname: Lee
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics ; The Catholic University of Korea Seoul; St. Mary's Hospital ; Seoul , Republic of Korea.
authors.forename: Sangil
authors.initials: S
authors.lastname: Jeon
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics ; The Catholic University of Korea Seoul; St. Mary's Hospital ; Seoul , Republic of Korea.
authors.forename: Seunghoon
authors.initials: S
authors.lastname: Han
authors.affiliation: a Department of Clinical Pharmacology and Therapeutics ; The Catholic University of Korea Seoul; St. Mary's Hospital ; Seoul , Republic of Korea.
authors.forename: Dong-Seok
authors.initials: DS
authors.lastname: Yim
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D000992:Antitoxins / Q000097:blood; D044466:Asian People; D004168:Diphtheria Toxoid / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D022422:Diphtheria-Tetanus Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D064368:Healthy Volunteers; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods*; D007273:Injections, Intramuscular; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D000992:Antitoxins; D004168:Diphtheria Toxoid; D022422:Diphtheria-Tetanus Vaccine; D010919:Placebos; D013745:Tetanus Toxoid
keywords: BR-TD-1001; adult; immunogenicity; safety; tetanus-diphtheria toxoid (Td) vaccine