Ebola
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Last high-risk contact within the last 5 days No signs or symptoms of EVD Age = 12 years Signed and dated informed consent to take part in the trial
Exclusion criteria
Exclusion criteria: Previous vaccination with Ervebo or any other EVD vaccine less than 5 years ago (declared by the participant) History of confirmed EVD less than 5 years ago (declared by the participant) Pregnant women (positive pregnancy test) Breastfeeding women Hypersensitivity to one of the investigational medicinal products (IMP) or to their excipients (declared by the participant) Declared severe renal or hepatic insufficiency Participation in another therapeutic or vaccination trial for EVD Any other reason which, at the investigator's discretion, would compromise the participant's safety and cooperation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate of EVD at 21 days in contacts at high risk of EVD receiving a PEP strategy Ervebo + Inmazeb or obeldesivir vs. Ervebo alone | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparing safety and tolerance Compare the severity of EVD Compare the proportion of deaths Describe changes in viral load Estimating cost-effectiveness | — |
Countries
Democratic Republic of the Congo
Contacts
International Project Manager ALIMA