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 No serious adverse event occurred, and no subject was withdrawn from the study for safety.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 language | English |
|---|---|
| Pages (from-to) | 2440-2445 |
| Number of pages | 6 |
| Journal | Human Vaccines and Immunotherapeutics |
| Volume | 11 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 2015 |
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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 journal › Article
}
TY - JOUR
T1 - Safety and immunogenicity of a single intramuscular dose of a tetanus-diphtheria toxoid (Td) vaccine (BR-TD-1001) in healthy Korean adult subjects
AU - Hong, Taegon
AU - Chung, Yong Ju
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
PY - 2015
Y1 - 2015
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.
KW - Adult
KW - BR-TD-1001
KW - Immunogenicity
KW - Safety
KW - Tetanus-diphtheria toxoid (Td) vaccine
UR - http://www.scopus.com/inward/record.url?scp=84953851814&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84953851814&partnerID=8YFLogxK
U2 - 10.1080/21645515.2015.1054582
DO - 10.1080/21645515.2015.1054582
M3 - Article
C2 - 26091286
AN - SCOPUS:84953851814
VL - 11
SP - 2440
EP - 2445
JO - Human Vaccines and Immunotherapeutics
JF - Human Vaccines and Immunotherapeutics
SN - 2164-5515
IS - 10
ER -