Evaluation of Immunogenicity and Safety of the New Tetanus-Reduced Diphtheria (Td) Vaccines (GC1107) in Healthy Korean Adolescents: A Phase II, Double-Blind, Randomized, Multicenter Clinical Trial

被引:1
作者
Rhim, Jung-Woo [1 ]
Lee, Kyung-Yil [1 ]
Kim, Sang-Yong [1 ]
Kim, Jong-Hyun [1 ]
Kim, Hyun-Hee [1 ]
Kim, Hwang Min [2 ]
Choi, Young-Youn [3 ]
Ma, Sang-Hyuk [4 ]
Kim, Dong-Ho [5 ]
Ahn, Dong Ho [6 ]
Kang, Jin-Han [1 ]
机构
[1] Catholic Univ Korea, Dept Pediat, Seoul 137701, South Korea
[2] Yonsei Univ, Wonju Coll Med, Dept Pediat, Wonju, South Korea
[3] Chonnam Natl Univ Hosp, Dept Pediat, Kwangju, South Korea
[4] Changwon Fatima Hosp, Dept Pediat, Chang Won, South Korea
[5] Korea Canc Ctr Hosp, Dept Pediat, Seoul, South Korea
[6] Green Cross Co, Res Ctr, Yongin, South Korea
关键词
Tetanus-Reduced Diphtheria (Td) Vaccine; Immunogenicity; Safety; ADVERSE-REACTIONS; TOXOID TD; VACCINATION; BOOSTER; REACTOGENICITY;
D O I
10.3346/jkms.2013.28.4.586
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
This phase II clinical trial was conducted to compare the immunogenicity and safety of a newly developed tetanus-reduced diphtheria (Td) vaccine (GC1107-T5.0 and GC1107-T7.5) and control vaccine. This study was also performed to select the proper dose of tetanus toxoid in the new Td vaccines. Healthy adolescents aged between 11 and 12 yr participated in this study. A total of 130 subjects (44 GC1107-T5.0, 42 GC1107-T7.5 and 44 control vaccine) completed a single dose of vaccination. Blood samples were collected from the subjects before and 4 weeks after the vaccination. In this study, all subjects (100%) in both GC1107-T5.0 and GC1107-T7.5 groups showed seroprotective antibody levels (>= 0.1 U/mL) against diphtheria or tetanus toxoids. After the vaccination, the geometric mean titer (GMT) against diphtheria was significantly higher in Group GC1107-T5.0 (6.53) and GC1107-T7.5 (6.11) than in the control group (3.96). The GMT against tetanus was 18.6 in Group GC1107-T5.0, 19.94 in GC1107-T7.5 and 19.01 in the control group after the vaccination. In this study, the rates of local adverse reactions were 67.3% and 59.1% in GC1107-T5.0 and GC1107-7.5, respectively. No significant differences in the number of adverse reactions, prevalence and degree of severity of the solicited and unsolicited adverse reactions were observed among the three groups. Thus, both newly developed Td vaccines appear to be safe and show good immunogenicity. GC1107-T5.0, which contains relatively small amounts of tetanus toxoid, has been selected for a phase III clinical trial.
引用
收藏
页码:586 / 592
页数:7
相关论文
共 22 条
[1]   Immunogenicity and reactogenicity of a single dose of a diphtheria-tetanus-acellular pertussis component vaccine (DTaP) compared to a diphtheria-tetanus toxoid (Td) and a diphtheria toxoid vaccine (d) in adults [J].
Bartels, I ;
Jüngert, J ;
Lugauer, S ;
Stehr, K ;
Heininger, U .
VACCINE, 2001, 19 (23-24) :3137-3145
[2]   ADVERSE REACTIONS AFTER DIPHTHERIA TETANUS BOOSTER IN 10-YEAR-OLD SCHOOLCHILDREN IN RELATION TO THE TYPE OF VACCINE GIVEN FOR THE PRIMARY VACCINATION [J].
BLENNOW, M ;
GRANSTROM, M ;
STRANDELL, A .
VACCINE, 1994, 12 (05) :427-430
[3]  
Centers for Disease Control and Prevention, 2004, EP PREV VACC PREV DI, P65
[4]   Immunogenicity and Safety of Diphtheria-tetanus Vaccine in Adults [J].
Choi, Jung-Hyun ;
Choo, Eun Ju ;
Huh, Aejung ;
Choi, Su-Mi ;
Eom, Joong Sik ;
Lee, Jin Seo ;
Park, Sun Hee ;
Kang, Jin Han .
JOURNAL OF KOREAN MEDICAL SCIENCE, 2010, 25 (12) :1727-1732
[5]  
GIL A, 1995, MED CLIN-BARCELONA, V104, P126
[6]  
Hur JK., 2001, KOREAN J INFECT DIS, V33, P104
[7]   Frequency of medically attended adverse events following tetanus and diphtheria toxoid vaccine in adolescents and young adults: a Vaccine Safety Datalink study [J].
Jackson, Lisa A. ;
Yu, Onchee ;
Belongia, Edward A. ;
Hambidge, Simon J. ;
Nelson, Jennifer ;
Baxter, Roger ;
Naleway, Allison ;
Gay, Charlene ;
Nordin, James ;
Baggs, James ;
Iskander, John .
BMC INFECTIOUS DISEASES, 2009, 9 :165
[8]  
Kang JH, 2000, KOREAN J INFECT DIS, V32, P1
[9]  
Kang JH, 2007, ASSESSMENT ADULT TD, P32
[10]   The need of Td vaccination according to the changes of tetanus and diphtheria immunity [J].
Kang, Jin Han .
JOURNAL OF THE KOREAN MEDICAL ASSOCIATION, 2008, 51 (02) :127-136