Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Maternal Serological Profile
研究概览
简要总结
This is a prospective longitudinal cohort study to evaluate the impact of COVID-19 vaccination and booster on maternal and infant immunity against COVID-19 variants over time.
详细描述
We will enroll 100 pregnant patients who have received COVID-19 mRNA booster as well as 100 breastfeeding patients who have received COVID-19 mRNA booster. Participants will be following longitudinally through 3 months post partum, or 3 months post enrollment for those in the breastfeeding cohort. Maternal blood will be collected, as will cordblood at delivery, breastmilk, and infant samples.
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
- 13 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton gestation
- •Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding
排除标准
- •Multifetal gestation
- •Unable to provide consent
研究组 & 干预措施
COVID-19 booster in pregnancy
Pregnant singletons who have received COVID-19 booster in pregnancy
干预措施: Bivalent COVID-19 Booster (Drug)
COVID-19 booster in breastfeeding
Breastfeeding individuals who have received COVID-19 booster while breastfeeding
干预措施: Bivalent COVID-19 Booster (Drug)
结局指标
主要结局
Maternal Serological Profile
时间窗: 3 months
Quantitative Maternal IgG to SARS CoV2 spike and other domains
Maternal Functional Immunity
时间窗: 3 months
Quantitative Antibody neutralization capacity
次要结局
- Breastmilk serological profile(3 months)
- Infant serological profile(3 months old)
- Infant functional immunity(3 months old)
- Infant oral immunity(3 months)
研究者
Rupsa C. Boelig
Assistant Professor
Thomas Jefferson University