COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15686

Fatima Mayat

mayatf@phru.co.za

2021-02-13

Recruiting

nonRCT

Non-randomized

Crossover

Open label

multi-center

Prevention

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 Known pregnancy 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. Immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt throughout the stud

1

South African Medical 7505 Council

18

99

South Africa

Health workers

N/A

500000

Rates of hospitalizations and deaths among vaccinated HCWs versus general unvaccinated population

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "1", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]