International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,399
- 试验地点
- 11
- 主要终点
- 1. To characterize immunogenicity (by measurement of anti-Spike [S] antibody [Ab]) of available COVID-19 vaccines in the overall study population, in each of the countries and in defined subgroups
研究概览
简要总结
InVITE is funded by NIAID and is conducted in multiple international sites (approximately 20 sites across 7 countries).
This is a study of adults who receive locally available COVID-19 vaccines through local vaccination programs. Persons will be enrolled within one day (before or after) of receipt of a COVID-19 vaccine. The study will enroll participants who receive COVID-19 vaccination at local clinics and/or study sites.
详细描述
This is a multicenter study of COVID-19 vaccine immunogenicity and durability, and breakthrough serious acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infections in people who receive a COVID-19 vaccine through their country's national vaccination programs. Participants will be enrolled upon signing the informed consent within a day of receipt of a COVID-19 vaccine (before or after). The study team will not be administering the vaccine; receipt of vaccine will be provided through each country's vaccine program. Blood specimens will be collected to measure the immune response to the vaccine. Participants may be asked to contact study staff at any time during the study for evaluation if they develop symptoms consistent with SARS-CoV-2 infection, at which time they will be counseled about the need for a medical evaluation that may include collection of an upper airway swab for diagnosis (and research) and a blood sample for research. Infections will be confirmed by molecular or antigen (Ag) testing at the time of symptoms, and swabs will be collected and stored for viral sequencing and analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
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
- •18 years of age or older.
- •Ability to provide informed consent.
- •Enrollment within one day (before or after) of receipt of COVID-19 vaccine.
- •Willingness to be evaluated (including collection of blood and nasopharyngeal samples) during the prescribed study visits and/or during acute illness consistent with SARS-CoV-2 infection during the study period.
- •Willingness to allow storage of biological samples for research testing as outlined in this protocol.
排除标准
- •Any acute or chronic condition that, in the opinion of the investigator, is a contraindication to participation in this study; for example, acute febrile illness.
- •Inability to comply with study visits.
结局指标
主要结局
1. To characterize immunogenicity (by measurement of anti-Spike [S] antibody [Ab]) of available COVID-19 vaccines in the overall study population, in each of the countries and in defined subgroups
时间窗: 2 months
Measured by amount of Anti-S Ab at 2 months after completion of vaccine regimen.
次要结局
- Evaluate duration of immunogenicity(1 day, 2 months, 10 months)
- Evaluate immunogenicity in predefined subgroups (by age, body mass index [BMI], comorbidities, HIV, breakthrough infection, or evidence of prior infection with SARS-CoV-2).(1 day, 2 months, 10 months)
- Characterize virus causing breakthrough infections using viral genomic sequencing.(1 day)
- Compare immunogenicity between different vaccines.(2 months)
- Evaluate infection rates after vaccination.(1 day)