Ebola Virus Disease Clinical Trial
Official title:
Phase IIa Pilot Study Evaluating the Efficacy of a Monoclonal Antibody and Vaccine-based Post-exposure Prophylaxis Strategy in High-risk Contact Cases of Ebola Virus Disease Infection
- Three measures are currently being implemented to control Ebola outbreaks: - Monitoring of contacts - Isolation and treatment of sick people - Vaccination of the population in high-risk areas. - In contacts with high viral exposure and therefore a high risk of incubation and rapid expression of infection, the r-VSV-ZEBOV vaccine does not provide adequate protection because vaccine antibody production is effective 6 to 10 days after administration. - Specific monoclonal antibodies (Mab) from the Regeneron and mAb114 research specialties have been shown to be effective in reducing mortality in patients with Ebola virus disease (EVD). - Their use in a single parenteral administration and good tolerability make them candidates for use in post-exposure prophylaxis (PEP) in individuals at high risk of viral exposure. - A comprehensive strategy for the protection of high-risk contacts must therefore be implemented, including the vaccine and the Mabs, to ensure both immediate and prolonged protection. Indeed, the efficacy of the vaccine is likely to be diminished when co-administered with Mabs, as both strategies share the same viral target (the GP envelope glycoprotein) and the vaccine is replicative (and therefore may be inhibited by Mabs). PROVAE aim to evaluate the effectiveness of a comprehensive strategy to prevent transmission of MVE in contacts at high risk of infection, including (i) post-exposure prophylaxis with Mabs and (ii) vaccination with r-VSV-ZEBOV.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00374309 -
Experimental Vaccine for Prevention of Ebola Virus Infection
|
Phase 1 | |
| Completed |
NCT03098862 -
PREVAIL VI: Identification of Host Genetic Factors Underlying Ebola Virus Disease Risk, Mortality, Long-term Sequelae, Viral RNA Persistence, Humoral Immunity, and Ebola Vaccine Response
|
||
| Completed |
NCT02509494 -
Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
|
Phase 3 | |
| Recruiting |
NCT06093646 -
Addressing Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Central Uganda
|
N/A | |
| Completed |
NCT02495246 -
A Study to Assess Ebola Vaccines ChAd3-EBO-Z and Ad26.ZEBOV
|
Phase 1 | |
| Completed |
NCT04906629 -
INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees
|
Phase 1 | |
| Completed |
NCT05064956 -
Ad26.ZEBOV Booster in HIV+ Adults Previously Vaccinated With Ad26.ZEBOV/MVA-BN-Filo (EBOVAC HIV+ Booster Study)
|
Phase 2 | |
| Not yet recruiting |
NCT06126822 -
Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination With the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC
|
Phase 3 | |
| Withdrawn |
NCT04268966 -
An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola
|
Phase 2 | |
| Completed |
NCT02267109 -
Phase 1 Trial of Ebola Vaccine in Mali
|
Phase 1 | |
| Recruiting |
NCT02333578 -
Clinical Trial to Evaluate the Efficacy and Safety of Convalescent Plasma for Ebola Treatment
|
N/A | |
| Completed |
NCT02662855 -
Efficacy of Favipiravir Against Severe Ebola Virus Disease
|
Phase 2 | |
| Active, not recruiting |
NCT04152486 -
Effectiveness and Safety of a Heterologous, Two-dose Ebola Vaccine in the DRC
|
Phase 3 | |
| Terminated |
NCT04250168 -
Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response
|
||
| Completed |
NCT03161366 -
Providing Additional Information on the Safety and Effectiveness of an Ebola Vaccine
|
Phase 3 | |
| Completed |
NCT03140774 -
Persistence of the Immune Response After Immunisation With Ebola Virus Vaccines
|
||
| Suspended |
NCT03462004 -
Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein
|
Phase 1 | |
| Active, not recruiting |
NCT02876328 -
Partnership for Research on Ebola VACcinations
|
Phase 2 | |
| Not yet recruiting |
NCT05202288 -
Pilot Study Evaluating the Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers
|
Phase 2 | |
| Completed |
NCT02368119 -
Ebola CVD-Mali #2000 (Bivalent) VRC-EBOAdc069-00-vp (cAd3-EBO)
|
Phase 1 |