Safety and immunogenicity of a single intramuscular dose of a tetanus-diphtheria toxoid (Td) vaccine (BR-TD-1001) in healthy Korean adult subjects

Taegon Hong, Yong Ju Chung, Tae Yeon Kim, Ik Hwan Kim, Yong Kyung Choe, Jongtae Lee, Sangil Jeon, Seunghoon Han, Dong Seok Yim

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 No serious adverse event occurred, and no subject was withdrawn from the study for safety.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.

Original languageEnglish
Pages (from-to)2440-2445
Number of pages6
JournalHuman Vaccines and Immunotherapeutics
Volume11
Issue number10
DOIs
Publication statusPublished - 2015

Fingerprint

Diphtheria Toxoid
Tetanus Toxoid
Diphtheria
Tetanus
Placebos
Safety
Anti-Idiotypic Antibodies
Vaccination
Vaccines
Clinical Trials, Phase I
Drug-Related Side Effects and Adverse Reactions
Immunity
Maintenance
Injections
Antibodies
Therapeutics

Keywords

  • Adult
  • BR-TD-1001
  • Immunogenicity
  • Safety
  • Tetanus-diphtheria toxoid (Td) vaccine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

Cite this

Safety and immunogenicity of a single intramuscular dose of a tetanus-diphtheria toxoid (Td) vaccine (BR-TD-1001) in healthy Korean adult subjects. / Hong, Taegon; Chung, Yong Ju; Kim, Tae Yeon; Kim, Ik Hwan; Choe, Yong Kyung; Lee, Jongtae; Jeon, Sangil; Han, Seunghoon; Yim, Dong Seok.

In: Human Vaccines and Immunotherapeutics, Vol. 11, No. 10, 2015, p. 2440-2445.

Research output: Contribution to journalArticle

Hong, Taegon ; Chung, Yong Ju ; Kim, Tae Yeon ; Kim, Ik Hwan ; Choe, Yong Kyung ; Lee, Jongtae ; Jeon, Sangil ; Han, Seunghoon ; Yim, Dong Seok. / Safety and immunogenicity of a single intramuscular dose of a tetanus-diphtheria toxoid (Td) vaccine (BR-TD-1001) in healthy Korean adult subjects. In: Human Vaccines and Immunotherapeutics. 2015 ; Vol. 11, No. 10. pp. 2440-2445.
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AU - Kim, Tae Yeon

AU - Kim, Ik Hwan

AU - Choe, Yong Kyung

AU - Lee, Jongtae

AU - Jeon, Sangil

AU - Han, Seunghoon

AU - Yim, Dong Seok

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N2 - 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.

AB - 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.

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