CoVacc - Immune Response to Vaccination Against Covid-19, an Open Multicenter Phase IV Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 5
- 主要终点
- Change in proportion of participants with detectable specific IgG antibodies after vaccination over time.
研究概览
简要总结
The study investigates the immune response after vaccination in individuals with and without pre-existing immunity to Coronavirus disease (COVID) -19. The participants are followed and sampled up to 4 years after vaccination. Blood samples are collected at different timepoints to analyze immune response.
The aim is to investigate the level of specific antibodies to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) yearly, up to 4 years after vaccination.
详细描述
The main objective is to investigate if the antibody development to SARS-CoV-2 S protein differ after vaccination in those who have had a previous SARS-CoV-2 infection compared to Covid-19 naive individuals.
The secondary objective is to improve the understanding of the cellular and serological immune response after vaccination against COVID-19 in these groups.
Individuals with and without pre-existing immunity to COVID-19 are included in the study. They are included after informed consent at sites where they receive vaccines against COVID-19 within the national and regional vaccine campaign.
The study includes all approved COVID-19 vaccines with marketing authorization in Sweden.
Persons are enrolled after the first or second dose of vaccination and followed 4 years after vaccination. Blood is collected at inclusion and 3 months, 6 months, 1 year, 2 years, 3 years and 4 years after vaccination to assess the immune response.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Consents to participate in the study
- •Age ≥ 18 years
排除标准
- •Age <18 years
- •Incapable of giving informed consent
- •Contraindication to vaccination
- •Severe disease
- •Ongoing treatment that is judged to affect the vaccine response (Does not include Rituximab which is allowed after individual consideration). Steroids > 15 mg orally per day.
研究组 & 干预措施
Post-COVID-19
Persons with a verified previous COVID-19 infection
干预措施: Vaccination (Drug)
COVID-19 naive
Persons that have no history of COVID-19
干预措施: Vaccination (Drug)
结局指标
主要结局
Change in proportion of participants with detectable specific IgG antibodies after vaccination over time.
时间窗: 1 and 6 months, 1, 2, 3, and 4 years after vaccination
Immune response will be measured as the proportion of participants (in % of all vaccinated individuals) with detectable specific IgG antibodies after vaccination at each time-point (in months after vaccination).
Change in levels of specific IgG antibody against SARS-CoV-2 after vaccination over time.
时间窗: 1 and 6 months, 1, 2, 3, and 4 years after vaccination.
Levels of specific IgG antibody against SARS-CoV-2 will be measured as optical density, OD in a specific Spike-protein IgG ELISA at each time-point.
次要结局
- Levels of markers for immune response after infection and vaccination against COVID-19 in COVID-naive versus COVID experienced individuals.(Change of markers for cellular and serological immune response over time measured at 1 and 6 months, 1, 2, 3, and 4 years after vaccination)