Status:
COMPLETED
Sisonke (Together): OPEN LABEL TRIAL COVID-19
Lead Sponsor:
Wits Health Consortium (Pty) Ltd
Collaborating Sponsors:
National Department of Health of South Africa
National Institute for Communicable Diseases, South Africa
Conditions:
SARS (Severe Acute Respiratory Syndrome)
Eligibility:
All Genders
18-105 years
Phase:
PHASE3
Brief Summary
To monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) in South Africa
Detailed Description
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 Op...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- Exclusion criteria
- 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.
- Note:
- • 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
Exclusion
Key Trial Info
Start Date :
February 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
477102 Patients enrolled
Trial Details
Trial ID
NCT04838795
Start Date
February 17 2021
End Date
March 31 2022
Last Update
August 1 2022
Active Locations (31)
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1
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
Mthatha, Eastern Cape, South Africa, 5100
2
PHOENIX Pharma Pty Ltd
Port Elizabeth, Eastern Cape, South Africa, 6001
3
Josha Research
Bloemfontein, Free State, South Africa, 9300
4
CRISMO Research Centre, Dr Bhekithemba
Germiston, Gauteng, South Africa, 1401