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serious adverse event occurred, and no subject was withdrawn from the study for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