drugset / Trial / NCT05148845
Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study.
Phase 3
Completed
500000 enrolled
Wits Health Consortium (Pty) Ltd
Bio Analytical Research Corporation · collabBioVac · collabBiocair · collabClinical Laboratory Services · collabDis-Chem Pharmacy · collabFred Hutchinson Cancer Center · collabHutchinson Center Research Institute of South Africa (HCRISA) · collabInstitute of Infectious Disease and Molecular Medicine · collabJanssen Vaccines & Prevention B.V. · collabKwaZulu-Natal Research Innovation and Sequencing Platform - KRISP · collabNational Department of Health of South Africa · collabNational Institute of Communicable Diseases - NICD · collabRight to Care · collab
Non-randomizedSingle-groupOpen-labelPrevention
Summary
To evaluate the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine plus a homologous boostwith Ad26.COV2.S COVID-19 vaccine among Sisonke participants as compared to unboosted Sisonkeparticipants; vaccinated; and unvaccinated populations in South Africa
Timeline
- Start
- 2021-11-10
- Primary completion
- 2022-01-31
- Completion
- 2023-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ad26.COV2.S | Vaccine | — | — |
| Subject | mRNA-1273 | Messenger RNA (mRNA) | — | — |