drugset / Trial / NCT05909358
Solidarity/Tokomeza Ebola Trial
Phase 1/2
Not yet recruiting
2121 enrolled
Makerere University
Epicentre · collabMRC/UVRI and LSHTM Uganda Research Unit · collabMakerere University Lung Institute · collabMakerere University Walter Reed Program · collabMinistry of Health, Uganda · collabUganda Virus Research Institute-International Aids Vaccine Initiative · collab
RandomizedParallel-groupTriple-blindBasic science
Summary
The TokomezaPlus Ebola trial is a phase I/II double blind randomised clinical trial designed to assess the safety and immunogenicity of candidate SUDV vaccines in Uganda during the inter outbreak period. Uganda is prone to Ebola virus disease outbreaks especially those caused by the Ebola Sudan (SUDV) species. TokomezaPlus Ebola Vaccine trial protocol has two main components: a) Safety b) Immunogenicity and is designed to create a living protocol that will be used to study the safety and immunogenicity of SUDV-candidate vaccines in the East African EVD-prone countries.
Timeline
- Start
- 2023-07
- Primary completion
- 2027-09
- Completion
- 2027-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CAd3 | Vaccine | — | — |
| Subject | ChAdOx1 | Vaccine | — | — |
| Subject | rVSV-SUDV | Vaccine | — | — |
Indications
No indication recorded.