COMMUNITY - the COVID-19 Immunity Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,500
- 试验地点
- 2
- 主要终点
- Antibody responses following SARS-CoV-2 infection and/or vaccination
研究概览
简要总结
The principal aim of the COMMUNITY study is to investigate immune responses following SARS-CoV-2 infection and/or vaccination in healthcare workers and hospitalized COVID-19 patients. The study aims to enroll a total of 5,000 healthcare workers and 500 COVID-19 patients. All participants are enrolled at Danderyd Hospital in Stockholm, Sweden. Participants will be followed every four months with blood and mucosal sampling in addition to demographic and clinical data provided by the participants and from national registries.
Primary outcome:
- Antibody responses in blood and mucosa following SARS-CoV-2 infection and/or vaccination
Secondary outcomes:
- Cellular immune responses following SARS-CoV-2 infection and/or vaccination
- Antibody responses in blood and mucosa following following Influenza A/B infection and/or vaccination
- Antibody responses in blood and mucosa following following RSV A/B infection
Blood and mucosal samples are collected every 4 months and at tighter intervals in sub studies. PCR testing is conducted upon symptoms of respiratory infections and with regular intervals regardless of symptomatology in sub studies. Participants provide detailed demographic and clinical data through a smart phone application-based questionnaire. Data on infection and vaccination history is collected from national registries
详细描述
The COMMUNITY study is designed to longitudinally follow healthcare workers and recovered COVID-19 patients to assess SARS-CoV-2 immune responses over time. Follow-ups are conducted every four months, including serum, PBMC, and mucosa (saliva and nasal secretions) samples. Sub studies with additional samplings and PCR screenings are conducted with regular intervals to assess vaccine responses and correlates to protection against infection.
Analyses include:
- Quantification and characterization of antibody responses
- Evaluation of T and B-cell responses
- RT-qPCR detection of viral infection
- Mucosal microbiome evaluation
Clinical and demographic data, including information on hospital workplace, exposure, immunosuppressive treatments or conditions, and results from SARS-CoV-2 Rapid Diagnostic Tests, are collected at each follow-up through a smartphone-based app system. Data on SARS-CoV-2 infections and vaccinations are obtained from national registries. In addition, data from home based PCR-screenings are continuously being monitored for SARS-CoV-2, Influenza and RSV infections.
All samples are stored in Biobank Sweden.
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
- •Health care workers: Employment at Danderyd hospital at time of enrollment
- •COVID-19 patients: Admitted to Danderyd Hospital with confirmed SARS-CoV-2 infection at time of enrollment
排除标准
- •No exclusion criteria
结局指标
主要结局
Antibody responses following SARS-CoV-2 infection and/or vaccination
时间窗: 2022-2026
Antigen-specific IgG and IgA responses in serum, saliva and nasal secretions (trajectories over time and correlates to protection against infection)
次要结局
- Antibody responses following Influenza A/B infection and/or vaccination(2022-2026)
- Antibody responses following RSV infection(2020-2026)
- Cellular immune responses following SARS-CoV-2, Influenza A/B and RSV A/B infection and/or vaccination(2020-2026)
研究者
Charlotte Thålin
MD, PhD
Karolinska Institutet