Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ervebo · 1 trial · 1 indication
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...
Ervebo is an investigational monoclonal antibody being studied for the prevention of Ebola Virus Disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in healthy volunteers to assess its impact on the immune response when administered before vaccination.
Ervebo is a monoclonal antibody designed to target the Ebola virus. As a monoclonal antibody, it works by binding to specific components of the virus to neutralize it. The drug is being studied for its potential to prevent Ebola Virus Disease, though its exact molecular target has not been specified in the available information.
Ervebo is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. Regeneron is conducting clinical trials to evaluate the safety and efficacy of Ervebo for the prevention of Ebola Virus Disease.
Ervebo is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is designed to evaluate the drug's effect on the immune response to Ebola vaccination in healthy volunteers.
Ervebo is being studied in a Phase 2 clinical trial registered as NCT05202288. This trial, titled "Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers," is not yet recruiting and aims to enroll 132 participants. The study is active-controlled and randomized.
No, Ervebo is not the same as Inmazeb. Ervebo is an investigational monoclonal antibody being developed by Regeneron Pharmaceuticals for Ebola Virus Disease. Inmazeb is a separate drug that is being studied in combination with Ervebo in a clinical trial to assess the impact of timing between their administrations on the immune response.