Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05202288 | Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers | PHASE2 | NOT YET_RECRUITING | 132 | — | — | Jan 1, 2027 | Aug 1, 2027 | Jan 22, 2026 | - | — |
The level will be evaluated with a pseudo-type plaque reduction neutralization test
| Arm | Type | Description |
|---|---|---|
| Ervebo 72 million PFU | ACTIVE_COMPARATOR | The control arm (vaccination alone) will serve to characterize the immune response to the vaccine and it will be used as a comparator of vaccine immune response in the intervention arms. Administration at D1. |
| Inmazeb 150mg/kg | ACTIVE_COMPARATOR | This second control arm of mAb alone will serve to characterize the pharmacokinetic profile of mAb in the Guinean population. Administration at D1. |
| Inmazeb 150mg/kg + Ervebo 72 million PFU | EXPERIMENTAL | The Arm 3, is a concomitant administration of the antibody and the vaccine at D1. |
| Inmazeb 50mg/kg + Ervebo 72 million PFU | EXPERIMENTAL | The Arm 4, is a concomitant injection of different-dose of the antibody and the vaccine. This design mimics a time interval of 15 days between Ervebo and Inmazeb administration. The administration will be at D1. These may help define a time interval between Ervebo administration and Inmazeb infusion. |
| Inmazeb 10mg/kg + Ervebo 72 million PFU | EXPERIMENTAL | The Arm 5, is a concomitant injection of different-dose of the antibody and the vaccine. This design mimics a time interval of 57 days between Ervebo and Inmazeb administration. The administration will be at D1. These may help define a time interval between Ervebo administration and Inmazeb infusion. |
| Inmazeb 0.7mg/kg + Ervebo 72 million PFU | EXPERIMENTAL | The Arm 6, is a concomitant injection of different-dose of the antibody and the vaccine. This design mimics a time interval of 169 days between Ervebo and Inmazeb administration. The administration will be at D1. These may help define a time interval between Ervebo administration and Inmazeb infusion. |
| Name | Type | Description |
|---|---|---|
| Ervebo | BIOLOGICAL | Administration of r-VSV-ZEBOV vaccine |
| Inmazeb | DRUG | Administration of Inmazeb |
Inclusion Criteria: * Available for the duration of the protocol follow-up; * Consent to participate ; * Agreed not to participate in another clinical research study until the end of the trial follow-up. Exclusion Criteria: * Prior history of EVD (self-reported); * Previous vaccination with r-VSV...