Seroprevalence and Antibody Profiling Against SARS-CoV2 in Children and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,056
- 试验地点
- 1
- 主要终点
- Seroconversion against SARS-CoV2 in children
研究概览
简要总结
The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.
详细描述
The fraction of undiagnosed but likely to transmit the virus is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV2. To adapt the epidemy control, it is essential to study the immunoprotection of the general population. A crucial question is the study of pauci or asymptomatic subjects, and in particular children who make mild forms, because they could act as a real reservoir for the spread of the virus. The serological study is essential in this context.
The serologic test Abbott will be used to study immunoprevalence. Institut Pasteur has validated test using neutralizing Ab. CEA will used a antibodies and antigen test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For hospitalized children or consulting at hospital
- •any child over 7 days old and under 17 years old in consultation or hospitalized for at most 4 days at AP-HP or CH Cayenne; Or any child over 7 days old and under 17 years old with a positive PCR at home, with an attending physician in a participating centre
- •Parent's agreement for blood, saliva and stool samples
- •Optional parent's agreement for nasopharynx swab
- •Optional parent's agreement for follow-up if PCR+
- •With an Health insurance
- •For children with potential COVID disease during the first wave
- •Any child over 7 days old and under 17 years, seropositive during the first wave
- •Or any child over 7 days old and under 17 years, with a previous inflammatory clinical disease potentially linked to SARS-cov2
- •With an Health insurance
- •Parent of the enrolled child
- •One parent of the enrolled child on ped-covid
- •Agreement for blood and saliva samples
- •Optional agreement for nasopharynx swab
- •Optional parent's agreement for follow-up if PCR+
- •With an Health insurance
- •For children SARS-coV2 positive
- •any child less then 18 years old
- •infected by SARS-coV2
- •Parent's agreement for blood, saliva samples
- •Optional parent's agreement for nasopharynx swab
- •With health insurance
- •For people living under the same roof of a child included in the study
- •any child or adult living under the same roof of a child SARS-coV2 positive and included in the study
- •With health insurance
排除标准
- •For hospitalized children or consulting at hospital
- •child younger than 7 days
- •Refusal of parent
- •Refusal of child
- •No health insurance
研究组 & 干预措施
Person living under the same roof as children included in the study
干预措施: nasopharyngeal swab (Biological)
Children SARS-coV2 positive
干预措施: saliva sample (Biological)
Person living under the same roof as children included in the study
干预措施: serology test (Biological)
Hospitalized children or consulting at hospital
干预措施: serology test (Biological)
Hospitalized children or consulting at hospital
干预措施: nasopharyngeal swab (Biological)
Hospitalized children or consulting at hospital
干预措施: rectal swab (Biological)
Hospitalized children or consulting at hospital
干预措施: saliva sample (Biological)
Parents of one included child
干预措施: serology test (Biological)
Parents of one included child
干预措施: nasopharyngeal swab (Biological)
Parents of one included child
干预措施: saliva sample (Biological)
Children with potential COVID disease during the first wave
干预措施: serology test (Biological)
Children with potential COVID disease during the first wave
干预措施: nasopharyngeal swab (Biological)
Children with potential COVID disease during the first wave
干预措施: rectal swab (Biological)
Children with potential COVID disease during the first wave
干预措施: saliva sample (Biological)
Children SARS-coV2 positive
干预措施: serology test (Biological)
Children SARS-coV2 positive
干预措施: nasopharyngeal swab (Biological)
Children SARS-coV2 positive
干预措施: rectal swab (Biological)
Person living under the same roof as children included in the study
干预措施: rectal swab (Biological)
Person living under the same roof as children included in the study
干预措施: saliva sample (Biological)
结局指标
主要结局
Seroconversion against SARS-CoV2 in children
时间窗: at inclusion
serology
次要结局
- Neutralization activity(at inclusion)
- Protective immunity(At 12 months)
- Measure of Ab antiN and Ab anti-S1/2(at inclusion)
- Transmission of the virus to the family(until 45 days follow-up)
- Saliva biofluid characteristics of COVID-19 infected(Until 1 year follow-up)
- seroconversion against SARS-CoV2 in parents(at inclusion)
- Positive qPCR in children(at inclusion)
- correlation between different Ab and qPCR and neutralization activity(at inclusion)
- Presence of the virus(Until 45 days follow-up)
- Positive qPCR in parents(at inclusion)
- Correlation between different Ab and qPCR(at inclusion)
- Ab profile and memory of immunity(at 12 months)
- Measure of Ab antiN and Ab anti-S1 and neutralization activity(at inclusion)
- Duration of viral carriage in stool, saliva and or nasopharynx(until 45 days if persistence of positive qPCR)
- saliva biofluid characteristics of COVID-19 infected(Until 1 year follow-up)
- Immune response(At inclusion)
- Correlation between antibody profile and viral clearance(until 45 days post onset)
- Reinfection(Until 1 year follow-up)
- Mucosal immunity(Until 1 year follow-up)
- Protective immunity(Day 3)
- Protective immunity(Day 7)
- Protective immunity(Day 15)
- Protective immunity(Day 45)
- Protective immunity(At 6 months)
- Ab profile and memory of immunity(At Day 3)
- Ab profile and memory of immunity(At Day 7)
- Ab profile and memory of immunity(At Day 15)
- Ab profile and memory of immunity(At Day 45)
- Ab profile and memory of immunity(At 6 months)
- Ab profile and memory of immunity(At 12 months)
- Presence of the virus(Until 1 year follow-up)
- Ab profile and memory of immunity(at Day 3)
- Ab profile and memory of immunity(at Day 7)
- Ab profile and memory of immunity(at Day 15)
- Ab profile and memory of immunity(at Day 45)
- Ab profile and memory of immunity(at 6 months)