Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- kinetics of Pertussis toxin (PT) IgG titers in infants
研究概览
简要总结
Young infants are most vulnerable to severe disease and even death when infected with Bordetella pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates from this disease. Maternal acquired pertussis-specific antibodies show low concentrations with short persistence in newborns creating a susceptibility gap for infection between birth and the first vaccinations. A possible strategy to protect infants from birth is pertussis vaccination during pregnancy, which will increase the amount of passively transferred maternal antibodies.
However, little is known regarding the effect of high titers of maternal antibodies on the infants immune responses to different pertussis vaccines (whole cell versus acellular). Humoral immune responses will be assessed in infants receiving whole cell versus infants receiving acellular pertussis vaccines. Functionality of the antibodies will also be analyzed.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing to be immunized with a pertussis containing vaccine during pregnancy
- •Intend to be available for follow-up visits and phone call through 19 months postpartum
- •Willing to have infant immunized with a pertussis containing vaccine at 2, 4, 6 months and 18 months of age according to EPI (Expanded Programme of Immunization) and receiving (randomized) either acellular pertussis (aP) (study vaccine) or a whole cell pertussis (wP) vaccine. Consent for participation of the child is needed by both married parents or by a single unmarried other.
- •At low risk for pregnancy related complications as determined by the investigator and a second trimester ultrasound with no significant abnormalities.
排除标准
- •Pregnant subjects
- •Multiple pregnancies
- •Serious obstetrical risk
- •Serious underlying medical condition
- •Significant mental illness
- •History of febrile illness (greater than or equal to 38°C) within the past 72 hours before injection
- •Previous severe reaction to any vaccine
- •Receipt of tetanus-diphtheria toxoid immunization within the past 1 month Receipt of an pertussis containing vaccine (Tdap) in the last 5 years
- •Receipt of a vaccine, blood product (excluding Rhogam) within the 4 weeks prior to injection through 4 weeks following injection and IVIG (Intravenous Immunoglobulins) within 12 weeks period. One month interval should be respected with another vaccine (except influenza) in orde to evaluate Adverse events following one or both vaccines (fever, local symptoms)
- •Receipt of an experimental drug during pregnancy
- •Anything in the opinion of the investigator that would prevent women from completing the study or put the woman at risk
- •Preterm delivery before 37 weeks of gestation
- •Serious underlying medical condition
- •Children suffering from primary humoral immune disorders; suffering from primary cellular immune deficiencies and disorders from the complete cascade
- •No informed consent from one or both married parents
- •Severe reactions to any vaccine
- •Anything in the opinion of the investigator that would prevent children from completing the study or put the child at risk
研究组 & 干预措施
Group B
Women will be vaccinated with an acellular pertussis containing vaccine (Boostrix) between 27 and 36 weeks of gestation. Children born from these mothers will be vaccinated according to the official recommendations in Thailand at 2, 4, 6 and 18 months with a pentavalent whole cell pertussis containing vaccine (Quinvaxem). OPV (oral poliovirus vaccine) will also be administered at 2, 4, 6 and 18 months.
干预措施: OPV (Biological)
Group B
Women will be vaccinated with an acellular pertussis containing vaccine (Boostrix) between 27 and 36 weeks of gestation. Children born from these mothers will be vaccinated according to the official recommendations in Thailand at 2, 4, 6 and 18 months with a pentavalent whole cell pertussis containing vaccine (Quinvaxem). OPV (oral poliovirus vaccine) will also be administered at 2, 4, 6 and 18 months.
干预措施: Boostrix (Biological)
Group B
Women will be vaccinated with an acellular pertussis containing vaccine (Boostrix) between 27 and 36 weeks of gestation. Children born from these mothers will be vaccinated according to the official recommendations in Thailand at 2, 4, 6 and 18 months with a pentavalent whole cell pertussis containing vaccine (Quinvaxem). OPV (oral poliovirus vaccine) will also be administered at 2, 4, 6 and 18 months.
干预措施: Quinvaxem (Biological)
Group A
Women will be vaccinated with an acellular pertussis containing vaccine (Boostrix) between 27 and 36 weeks of gestation. Children born from these mothers will be vaccinated according to the official recommendations in Thailand at 2, 4, 6 and 18 months with a hexavalent acellular pertussis containing vaccine (Infanrix hexa).
干预措施: Infanrix hexa (Biological)
Group A
Women will be vaccinated with an acellular pertussis containing vaccine (Boostrix) between 27 and 36 weeks of gestation. Children born from these mothers will be vaccinated according to the official recommendations in Thailand at 2, 4, 6 and 18 months with a hexavalent acellular pertussis containing vaccine (Infanrix hexa).
干预措施: Boostrix (Biological)
结局指标
主要结局
kinetics of Pertussis toxin (PT) IgG titers in infants
时间窗: from birth until 19 months of age
Measurement of anti- Pertussis Toxin (PT) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine
kinetics of Pertactin (Prn) IgG titers in infants
时间窗: from birth until 19 months of age
Measurement of anti- Pertactin (Prn) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine
kinetics of Filamentous haemagglutinin (FHA) IgG titers in infants
时间窗: from birth until 19 months of age
Measurement of anti- Filamentous Haemmaglutinin (FHA) immunoglobulin (IgG) antibodies at several time points following maternal vaccination during pregnancy and after infant immunization (priming and boosting) with an acellular or whole cell pertussis containing vaccine
次要结局
- Efficacy of the transplacental transport of IgG as assessed by the ratio of cord and maternal titers of IgG antibodies(Birth)
- Functionality of the anti-PT IgG antibodies in the infants after vaccination assessed with a newly validated luminescence based assay(At month 7 and month 19)
- Functionality of the maternal anti-PT IgG antibodies in the infants as assessed with a newly validated luminescence based assay(At birth)
研究者
Elke Leuridan, MD, PhD
Prof., MD, PhD
Universiteit Antwerpen