Open-label, Single-arm Phase 3B Implementation Study to Monitor the Effectiveness of the Single-dose Ad26.COV2.S COVID-19 Vaccine Among Health Care Workers in South Africa (VAC31518COV3012)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 477,102
- 试验地点
- 59
- 主要终点
- Number of severe COVID, hospitalizations and deaths in HCWs as compared with the general unvaccinated population in South Africa
研究概览
简要总结
To monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) in South Africa
详细描述
Purpose To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) as compared to the general unvaccinated population in South Africa
Study design Open-label, single-arm phase 3B vaccine implementation study
Rationale South Africa is severely affected by the global COVID-19 epidemic, but currently no vaccine has been rolled out. The recent promising results of the 'ENSEMBLE' trial conducted by Janssen in South Africa, and the availability of a limited amount of vaccine doses, provide the rationale for a cohort study of vaccinated HCWs to inform the larger vaccine rollout.
Study participants Health Care workers age 18 and above working in the South African public and private health care sector (N=500 000) Study sites Department of Health Vaccine administration sites across South Africa supported by the Sisonke (Together) (VAC31518COV3012) trial Research Site Investigators and Study Staff
Study duration Participants will receive a single dose of vaccine at enrolment; to monitor outcomes the DATCOV surveillance system and NICD line list will be reviewed for up to 2 years post-vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 105 Years（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
Number of severe COVID, hospitalizations and deaths in HCWs as compared with the general unvaccinated population in South Africa
时间窗: 24 Months
Rates of hospitalizations and deaths among vaccinated HCWs versus general unvaccinated population
次要结局
- The number of symptomatic SARSCoV-2 infections among vaccinated HCWs(24 Months)
- The vaccine uptake among HCWs in South Africa(12 Months)
- The measure of genetic diversity of breakthrough SARSCoV-2 infections(24 months)
- Monitor for safety and any unexpected adverse effects of the vaccine administration -pharmacovigilance(24 Months)
- Monitoring for asymptomatic infection in a sub-set (10 000) of HCWs(24 Months)