2024-517893-73-00招募中4 期
Maternal determinants of infant immunity to pertussis (MADI-02)
Universite Libre de Bruxelles1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年10月16日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The magnitude of the antibody responses to pertussis vaccination
研究概览
简要总结
The main objective of the project is to identify the determinants of antibody-mediated immunity to pertussis in infants born to mothers immunized during pregnancy. Specifically, the project aims to identify key predictors and potential determinants of vaccine responses in pregnant women, of the transfer of maternal antibodies to the newborn and of vaccine responses in infants.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •(Women) Age between 18 and 45 years
- •(Women) Eligible for Tdap vaccination
- •(Women) Last Pertussis vaccination > 12 months ago
- •(Women) Pregnant and non-pregnant women
- •(Infants) Infants of 2 months (+- 1 week) of age (boys and girls)
- •(Infants) Born after 35 weeks of gestation
- •(Infants) Birthweight above 2.5 kg
- •(Infants) Consent form signed by the parents
排除标准
- •(Women) Inability to understand the nature and extent of the study and the procedures required
- •(Infants) Severe neonatal distress
- •(Infants) Serious congenital abnormalities or congenital infection
- •(Women) Grade III/IV anemia
- •(Women) Acute infection at the time of immunization
- •(Women) Chronic infections such as HBV, HCV or HIV infection, acute toxoplasmosis
- •(Women) Current or recent use of immunosuppressive drugs
- •(Women) Active neoplasia
- •(Women) Other vaccination at the same time as pertussis vaccination (wash out of 4 weeks after other vaccinations and 28 days after Tdap vaccination)
- •(Pregnant women) Risk of premature delivery or intrauterine growth retardation
- •(Pregnant women) Twin or triplet pregnancies
结局指标
主要结局
The magnitude of the antibody responses to pertussis vaccination
The magnitude of the antibody responses to pertussis vaccination
次要结局
- Subclass and binding of pertussis-specific antibodies to Fc-receptors, complement and lectin-like receptors post vaccination.
- Functional antibody profiling post vaccination (including assays covering cytotoxicity, phagocytosis, cytokine production, antigen uptake)
- Antibody and B cell repertoire post vaccination
- The magnitude and quality of Tdap-specific T lymphocytes post vaccination
研究者
Arnaud Marchant
Scientific
Universite Libre de Bruxelles
研究点 (1)
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