Gestational Immunity for Transfer
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Antibodies transferred through breast milk (convalescent mothers)
研究概览
简要总结
This is a study prospective cohort study at an urban academic centre, with two parts:
- Health outcomes, and maternally transferred antibodies, in babies born to mothers who had antenatal COVID-19 and convalesced before delivery, followed up until 12 months of age
- Safety and protective properties of breast milk after lactating women are vaccinated against COVID-19
详细描述
This proposal aims to provide a multi-faceted approach to study how immunity may be transferred - both transplacentally and through breastfeeding, from mother to child, in the context of COVID-19.
We first recruit all babies delivered to mothers convalescent from antenatal COVID-19, to 1) follow up their growth and development, and 2) study the protective effects of antibodies transferred from mother to child transplacentally during pregnancy, as well as postnatally through breastfeeding. We compare these to a cohort of healthy controls whose mothers did not have COVID-19 during pregnancy.
Next, we compare the protective effects of antibodies transferred during breastfeeding from mother to child after lactating mothers are vaccinated against COVID-19, to that of natural infection. We also study the safety of breastfeeding after vaccination by looking for vaccine components in the breast milk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lives in Singapore
排除标准
- •Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders
结局指标
主要结局
Antibodies transferred through breast milk (convalescent mothers)
时间窗: From birth to 6 months of age
Binding and neutralising immunoglobulin A specific to SARS-CoV-2 spike and receptor-binding domain
Antibodies transferred through breast milk (vaccinated mothers)
时间窗: From just before vaccination, to 6 weeks after vaccination
Binding and neutralising immunoglobulin A specific to SARS-CoV-2 spike and receptor-binding domain
Transplacentally transferred antibodies
时间窗: From birth to 12 months of age
Binding and neutralising immunoglobulin G specific to SARS-CoV-2 spike and receptor-binding domain
次要结局
- General health(From birth to 12 months of age)