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 No serious adverse event occurred, and no subject was withdrawn from the study for safety.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: Taegon Hong, Yong-Ju Chung, Tae-Yeon Kim, Ik-Hwan Kim, Yong-Kyung Choe, Jongtae Lee, Sangil Jeon, Seunghoon Han, Dong-Seok Yim
• Journal: Human vaccines & immunotherapeutics (Hum Vaccin Immunother) Vol. 11 Issue 10 Pg. 2440-5 ( 2015) ISSN: 2164-554X [Electronic] United States
• PMID: 26091286 (Publication Type: Clinical Trial, Phase I, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Bacterial
• Antitoxins
• Diphtheria Toxoid
• Diphtheria-Tetanus Vaccine
• Placebos
• Tetanus Toxoid

Topics

• Adult
• Antibodies, Bacterial (blood)
• Antitoxins (blood)
• Asian People
• Diphtheria Toxoid (administration & dosage, adverse effects, immunology)
• Diphtheria-Tetanus Vaccine (administration & dosage, adverse effects, immunology)
• Double-Blind Method
• Drug-Related Side Effects and Adverse Reactions (epidemiology, pathology)
• Healthy Volunteers
• Humans
• Immunization, Secondary (methods)
• Injections, Intramuscular
• Male
• Placebos (administration & dosage)
• Tetanus Toxoid (administration & dosage, adverse effects, immunology)
• Treatment Outcome
• Young Adult