Covid-19 Vaccine Cohort in Specific Populations
试验速览
- 阶段
- 不适用
- 入组人数
- 6,920
- 试验地点
- 3
- 主要终点
- These primary outcome only concern the adult cohort. Humoral immunity to Covid-19 vaccination using 2 serological criteria:
研究概览
简要总结
Multicentre national cohort study with prospective data collection and biological specimen collection.
Ancillary study in this cohort : pediatric cohort with participants from 5 to 17 years old.
Enrollment complete for adult cohort. Active recruting for ancillary pediatric cohort.
详细描述
Primary Objective
1.Evaluate in a standardized manner in each subpopulation the humoral immune response to Covid-19 vaccination at 1, 6, 12, 24 months (M) after the last dose of vaccine (1 or 2 dose schedule depending on the vaccines) and standardized assessment of the humoral response 1 month after receipt of the third injection in participants receiving a third injection as recommended
Secondary objectives
- Evaluate the cellular immune response to Covid-19 vaccination at Inclusion, 6 and 24 months after the first injection (single-injection scheme) or after the second injection of the vaccine (two or three-injections regimens) in each subpopulation
- Compare the humoral immune response at 1, 6, 12, 24 months after the first injection (one-injection scheme) or after the second injection of vaccine (two- or three-injections regimens) of each subpopulation with a control group of subjects without the chronic diseases of interest and from any other diseases or treatment taht may have an influence on the immune response.
- Compare the humoral immune response after 3 injections (1 month after the third dose) to that after 2 injections (1 month after the second dose) in participants with received a third injection as current recommendations
- In each subpopulation, study the factors associated with the humoral immune response at 1 month and the persistence of the humoral immune response at 6, 12, 24 months as a function of age, stage of disease, treatments, type of vaccine (as well as characteristics specific to the subpopulations studied)
- Evaluate and characterize the humoral immune response for participants who received a booster dose with mRNA vaccine acording to recommendations in force
- Compare the humoral immune response between different specific subpopulations
- Describe the seroconversion for anti-nucleoprotein antibodies
- Immuno-virologically characterize vaccine failures (SARS-CoV2 infection) during follow-up
- Identify genetic determinants of the immune response based on the underlying pathology and ongoing treatments if applicable (response and resistance to vaccination)
Specifics secondary objectives for participants with the first dose of Astra-Zeneca vaccine and the second dose of Pfizer vaccine
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
These primary outcome only concern the adult cohort. Humoral immunity to Covid-19 vaccination using 2 serological criteria:
时间窗: before the second injection (if applicable)
* Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
Humoral immunity to Covid-19 vaccination using 2 serological criteria:
时间窗: Month 24
* Anti-Spike (test 1) and anti RBD (test 2) antibodies (quantitative Elisa) * Seroneutralization, by conventional in vitro seroneutralization test, for participants having test 1 and / or test 2 positive: percentage of patients with a neutralizing antibody titre specific to SARS-CoV-2 ≥20. Seroneutralization, by neutralization test on SARS-CoV-2 variants, in the first 50 participants included by subpopulation and with test 1 and / or test 2 positive: SARS-CoV-2 specific neutralizing antibodies titre
Percentage of participants seroconverting for Anti Nucleoprotein antibodies
时间窗: Month 24
(qualitative Elisa)
Seroconversion or increase of factor 2 titer of antibodies anti-Spike/anti-RBD between the second and the third dose for the participants with 3 injections
时间窗: Month 1 after the third dose
(qualitative Elisa)
Seroconversion or increased levels of anti-Spike/anti-RBD antibodies between the last injection of the initial vaccine regimen and the booster dose
时间窗: Month 1 after the booster dose
(qualitative Elisa)
次要结局
- For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : humoral and cellular immunity to Covid-19 vaccination(Month 1)
- These secondary outcome only concern the adult cohort. Cellular immunity to Covid-19 vaccination(Inclusion)
- Cellular immunity to Covid-19 vaccination(Month 24)
- For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of immediate adverse effects(within 15 minutes after injection of Pfizer ARNm vaccine)
- For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of adverse effects expected from the database(within 7 days after injection of Pfizer ARNm vaccine)
- For participants with first injection with Astra-Zeneca vaccine AZD1222 and second injection with Pfizer ARNm vaccine BNT161b2 : collection of adverse effects(within 28 days after injection of Pfizer ARNm vaccine)