Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Inmazeb · 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...
Inmazeb is being developed for Ebola Virus Disease. It is an investigational therapy from Regeneron Pharmaceuticals, Inc. (ticker: REGN) and is currently in Phase 2 clinical development. The only listed trial is in healthy volunteers and examines the impact of the delay between Inmazeb administration and vaccination with Ervebo on vaccine immune response.
Inmazeb is made by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron is the developer of the drug, and the company is responsible for its clinical development program in Ebola Virus Disease.
Inmazeb is in Phase 2 clinical development. The only listed trial is a Phase 2 study, and it is currently not yet recruiting. There are no completed trials listed for Inmazeb. The drug is investigational and has not been approved by the FDA for any indication based on the available information.
Inmazeb is being studied in one clinical trial: NCT05202288, titled "Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers." This Phase 2 trial has an enrollment of 132 participants, is active controlled, randomized, and is not yet recruiting.
No, Inmazeb and Ervebo are different products. Inmazeb is an investigational therapy developed by Regeneron Pharmaceuticals for Ebola Virus Disease. Ervebo is a vaccine that is referenced in the Inmazeb clinical trial NCT05202288, which examines the impact of the delay between Inmazeb administration and Ervebo vaccination on vaccine immune response.