Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Reduced-antigen, Combined Diphtheria, Tetanus, and Acellular Pertussis Vaccine (Tdap) in Pregnant Thai Women
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women
研究概览
简要总结
This study evaluated the seroprevalence of Bordetella pertussis antibodies and anti-pertussis antibody response after a single dose of reduced-antigen, combined diphtheria, tetanus, and acellular pertussis vaccine (Tdap) in pregnant Thai women.
All seronegative participants received Tdap, while seropositive participants were equally randomized into 2 groups. Half of seropositive participants received Tdap and the other half received tetanus-diphtheria (Td) as standard protocol.
详细描述
The primary objective of this study was to determine the seroprevalence of anti-pertussis toxin antibodies (anti-PT IgG) among pregnant Thai women. The secondary objectives were to evaluate antibody response after Tdap vaccination between seronegative and seropositive participants and to compare the different antibody titers at delivery among seropositive participants who received Tdap to those who received tetanus-diphtheria vaccine (Td). The sample size calculation was based on the primary objective. Randomized clinical trial was performed for the latter secondary objective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Thai pregnant women age at least 18 years
- •No known underlying disease
- •Singleton pregnancy without maternal or fetal complications
- •Gestational age not more than 20 weeks at the time of recruitment
- •Desired for delivery at Siriraj Hospital
排除标准
- •Pregnant women who have any contraindication to Tdap vaccine including
- •History of serious allergic reaction to any components of Tdap vaccine
- •History of seizure or coma after receiving Tdap vaccine in childhood
- •Having an underlying disease involving central nervous system (e.g., epilepsy, Guillain-Barré syndrome)
- •History of serious reactions after receiving Tdap vaccine (e.g., severe pain, severe swelling at the injection site)
- •Recently had Tdap vaccine injection
- •Denied for Tdap vaccine injection
结局指标
主要结局
The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women
时间窗: Four months
Percentage of participants who were seropositive for anti-pertussis toxin antibodies (anti-PT IgG). The overall number of 129 participants is greater than the number of 42 participants include in the Particiant Flow Module because it was the sample size calculated based on the primary objective, which was the seroprevalence of anti-pertussis antibodies in pregnant Thai women. Randomized clinical trial on 42 seropositive participants was performed for one of the secondary objectives, which was to compare the different anti-PT IgG at delivery among seropositive participants who received Tdap to those who received Td.
次要结局
- Change From Baseline in Anti-pertussis Toxin Immunoglobulin G Levels Among Seropositive Participants Who Received Tdap to Those Who Received Td(Eight months)
研究者
Nalat Sompagdee
Principal Investigator
Mahidol University