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

Author(s): Hong T(1), Chung YJ, Kim TY, Kim IH, Choe YK, Lee J, Jeon S, Han S, Yim DS.

Affiliation(s): Author information: (1)a Department of Clinical Pharmacology and Therapeutics , the Catholic University of Korea Seoul St. Mary's Hospital , Seoul , Republic of Korea.

Publication date & source: 2015, Hum Vaccin Immunother. ,

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 three 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 four weeks after injection. The antibody titers of the patients two and four 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 No serious adverse event occurred, and no subject was withdrawn from the study for safety.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 four 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.

Page last updated: 2015-08-10

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