2024-518692-56-00招募中4 期
The optimal timing of vaccination in pregnancy: a multi-dimensional mechanistic approach to measure immune responses in pregnant women (MATIMMUNE)
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Measurement of antibody levels and functional antibody characteristics in maternal blood with Tdap vaccination at different timings in pregnancy (measurement at baseline, after Tdap vaccination, at delivery and 6 months postpartum).
研究概览
简要总结
To assess the impact of timing of pertussis vaccination in pregnancy on humoral and cellular immune responses in pregnant women, at delivery and postpartum.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 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 and functional antibody characteristics in maternal blood with Tdap vaccination at different timings in pregnancy (measurement at baseline, after Tdap vaccination, at delivery and 6 months postpartum).
Measurement of antibody levels and functional antibody characteristics in maternal blood with Tdap vaccination at different timings in pregnancy (measurement at baseline, after Tdap vaccination, at delivery and 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 (measurement at baseline, after Tdap vaccination, at delivery and 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.
- Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in breastmilk 6 months postpartum after Tdap vaccination at different timings in pregnancy.
研究者
Kirsten Maertens
Scientific
University Of Antwerp
研究点 (1)
Loading locations...
相似试验
招募中
不适用
The Optimal Timing of Vaccination in PregnancyPertussis/Whooping CoughNCT06466629Elke Leuridan, MD, PhD96
招募中
不适用
Infants’ immunizations, their timing and the risk of allergic diseases (INITIAL) – an observational prospective cohort studyJ45.0J30.1L20T78Predominantly allergic asthmaAllergic rhinitis due to pollenAdverse effects, not elsewhere classifiedAtopic dermatitisDRKS00029677Gerhard-Kienle-Lehrstuhl, Fakultät für Gesundheit, Private Universität Witten/Herdecke gGmbH4,500
已完成
不适用
Time of day and influenza vaccination studyThis study involves aspects of ageing related to the immune response following vaccinationISRCTN70898162niversity of Birmingham (UK)400
进行中（未招募）
Unknown
Optimizing the time of day of influenza vaccine administratioInfluenza vaccinationISRCTN65770516ational Institute for Public Health and the Environment440
进行中（未招募）
1 期
Optimizing the time of day of influenza vaccine administration in adults aged 60-85 years: A randomized controlled trialInfluenzaCTIS2024-513558-30-00Rijksinstituut voor Volksgezondheid en Milieu (RIVM)440