The Optimal Timing of Vaccination in Pregnancy: a Multi-dimensional Mechanistic Approach to Measure Immune Responses in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy.
研究概览
简要总结
The central aim of this study is to investigate the optimal timing of vaccination in pregnant women. Therefore, pregnant women will be vaccinated against pertussis at different timepoints and blood and breast milk samples will be taken at several timepoints. The main objectives are to assess the impact of timing on humoral and cellular immune responses in pregnant women, on antibody characteristics transferred across the placenta and on transplacental transport efficiency. The impact of maternal pertussis vaccination and timing of maternal pertussis vaccination on breastmilk antibody composition will also be investigated, as well as the impact of vaccination during pregnancy on the mucosal uptake of breastmilk IgA antibodies by the infant respiratory and gastrointestinal tract.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Ability to provide informed consent.
- •Willing to be vaccinated with a Tdap vaccine during pregnancy.
- •Intend to be available for follow-up visits and phone call access until 6 months postpartum.
- •Influenza and COVID-19 vaccination during pregnancy (as per Belgian recommendations) is allowed.
排除标准
- •Vaccinated with an aP containing vaccine during the last 5 years
- •Significant mental illness (e.g. schizophrenia, psychosis, major depression)
- •Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection...).
- •Systemic treatment with immune suppressive medication, including chronic steroid use of > 10 mg prednisone or equivalent.
- •Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
- •Previous severe reaction to any vaccine
- •High risk for serious obstetrical complications.
结局指标
主要结局
Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy.
时间窗: 6 months postpartum
次要结局
- Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy.(6 months postpartum)
- Measurement of antibody levels in cord blood at delivery after Tdap vaccination at different timings in pregnancy to calculate the transport of antibodies across the placenta(At delivery)
- Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in breastmilk after Tdap vaccination at different timings in pregnancy.(6 months postpartum)
研究者
Elke Leuridan, MD, PhD
Principal Investigator
Universiteit Antwerpen