Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott)
研究概览
简要总结
The main objective of this study is to describe the humoral and cellular response to BNT162b2 vaccination in people over age 75 institutionalized in the long-term care units of the Paris Public Hospitals (APHP)
详细描述
This is an interventional study with minimal risk and constraints, multicenter with biological collection. Two populations are studied: patients and members of care staff.
The following data will be collected:
- For patients and staff: age, gender, existence of Coronavirus Disease 2019 (COVID-19) infection and whether or not it is symptomatic and date of first positive RT-PCR test, medical history
- For patients: nutritional status (loss of appetite, weight loss, body mass index, albuminemia)
Vaccination antibodies are measured using 3 blood sample:
The first carried out before the anti-Coronavirus Disease 2019 (COVID-19) vaccination; the second on D21 (shortly before the vaccination booster injection) and the third on D50-54.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •for patients:
- •Person aged 75 and over,
- •Hospitalized in a long-term care unit participating in the study,
- •Having agreed to be vaccinated with the BNT162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities,
- •Not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study,
- •Having given their written consent to participate in the study, or having not expressed their opposition to participating and whose legal guardian has given their consent.
- •Inclusion Criteria for younger adults (priority care staff):
- •Staff who have agreed to be vaccinated with the BNT162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities,
- •Not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study,
- •Having given their written consent to participate in the study.
排除标准
- 未提供
结局指标
主要结局
Measure plasma concentration of anti-RBD IgG antibodies in elderly using SARS-CoV-2 IgG II Quant assay technique (Abbott)
时间窗: 50 days
次要结局
- Measure plasma concentration of anti-RBD IgG antibodies in younger adults using SARS-CoV-2 IgG II Quant assay technique (Abbott)(50 days)
- Assess the percentage of patients with previous COVID-19 infection prior to vaccination(At inclusion)