Solidarity/Tokomeza Ebola Trial
ConditionSudan Ebola Virus Vaccines
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-65
SponsorMakerere University
About this trial
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.
Eligibility criteria
Qualifiers
Healthy volunteers aged 18-50 years from study communities
Healthy volunteers with a permanent home address
Able and willing to complete and provide written informed consent. In case the participant cannot read or write, the procedures must be explained to him/her and informed consent must be witnessed by a literate third party not involved with the conduct of the study
Participant must pass the informed consent test of understanding (TOU)
Disqualifiers
History of confirmed ebola virus diseases (SUDV, EBOV or BUDV)
Unwillingness of female participants to use effective contraception
Participation in an interventional clinical trial within 90 days of participation in this trial
Prior vaccination with any Ebola vaccine
Trial design
Treatments tested in this trial
- CAd3
- ChAdox1
- rVSV-SUDV
- Control
Treatment groups
2,121 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Makerere University
Lead sponsor
Makerere University Lung Institute
Collaborator
MRC/UVRI and LSHTM Uganda Research Unit
Collaborator
Makerere University Walter Reed Program
Collaborator
Epicentre
Collaborator
Uganda Virus Research Institute-International Aids Vaccine Initiative
Collaborator
Ministry of Health, Uganda
Collaborator
Source ClinicalTrials.gov