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
- 31
- 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
- •Age 18 and older
- •Health care worker in the private or public service
- •The President and Deputy President of South Africa* (The President and Deputy President of South Africa have been included in the protocol to address the issue of vaccine hesitancy. )
- •Willingness and ability to comply vaccination plan and other study procedures.
- •Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol.
- •Inclusion criteria for the sub-cohort
- •Age 18 and older
- •Health care worker in the private or public service
- •Willingness and ability to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures, with follow-up at an ENSEMBLE site.
- •Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol.
排除标准
- •Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant
- •Participant reports being pregnant at time of enrolment, planning conception within 3 months.
- •Participants who report breastfeeding at the time of enrolment will be excluded.
- •Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee.
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
- •Participants who have experienced major venous and arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not enrol in Sisonke.
- •Participants with a history of heparin-induced thrombocytopenia.
- •Vaccination within 14-90 days with other COVID19 or non-specific vaccines are not exclusionary but should be discussed with study PI or designee.
- •Conditions of interest:
- •We note that international reports of VITT have not identified a risk factor, nor does there appear to be any prothrombotic state that indicates a risk factor for this immune response.
- •Nevertheless, the Sisonke study will enrol participants with chronic history of severe clotting disorders only after consultation and approval of the study Protocol Safety Review Team (PSRT).
- •We have identified certain specific conditions of special interest such as:
- •cerebral venous sinus thrombosis,
- •antiphospholipid syndrome
- •Individuals on therapeutic anticoagulants for current or previous arterial or venous thrombosis or embolism
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)