Ebola Virus Disease Clinical Trial
Official title:
Partnership for Research on Ebola VACcinations (PREVAC)
The purpose of this study is to evaluate the safety and immunogenicity of three vaccine strategies that may prevent Ebola virus disease (EVD) events in children and adults. Participants will receive either the Ad26.ZEBOV (rHAd26) vaccine with a MVA-BN-Filo (MVA) boost, or the rVSVΔG-ZEBOV-GP (rVSV) vaccine with or without boosting, or placebo.
The purpose of this study is to evaluate the safety and immunogenicity of two Ebola virus disease (EVD) vaccines, Ad26.ZEBOV (rHAd26) and rVSVΔG-ZEBOV-GP (rVSV), in children and adults. These vaccines will be studied using three different strategies: the rHAd26 vaccine plus a MVA-BN-Filo (MVA) boost, and the rVSV vaccine with or without boosting. Participants will be randomized into five groups: the Ad26.ZEBOV vaccine with an MVA boost, the rVSV vaccine with or without boosting, or one of two placebo groups. At Day 0 (study entry), participants will receive the Ad26.ZEBOV vaccine, the rVSV vaccine, or placebo. At Day 56, participants assigned to the rVSV vaccine without a boost and the two placebo groups will receive placebo. Those initially given the Ad26.ZEBOV vaccine will receive the MVA boost. Those assigned to the boosted rVSV group will receive the rVSV boost. Additional study visits will occur on Days 7, 14, 28, and 63, and at Months 3, 6, 12, 24, 36, 48, and 60. Study visits may include blood collection and other assessments. Some participants may take part in substudies, which will include blood or saliva collection. After the Month 12 visit, during the long-term follow-up, the participants who received the placebo will be vaccinated with a single dose of rVSVΔG-ZEBOV-GP vaccine in Liberia and Mali and with the Ad26.ZEBOV/MVA-BN-Filo vaccine strategy in Guinea and Sierra Leone. The participants who received an incomplete Ad26.ZEBOV/MVA-BN-Filo vaccine strategy will be offered a single dose of the Ad26.ZEBOV or MVA-BN-Filo vaccine in Guinea and Sierra Leone and a single dose of rVSVΔG-ZEBOV-GP in Liberia and Mali. ;
| 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 | |
| Completed |
NCT02267109 -
Phase 1 Trial of Ebola Vaccine in Mali
|
Phase 1 | |
| Withdrawn |
NCT04268966 -
An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola
|
Phase 2 | |
| Not yet recruiting |
NCT04822376 -
Prophylaxis Vaccine Antibodies Ebola
|
Phase 2 | |
| 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 | |
| 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 |
NCT02658331 -
Evaluation of the FilmArray BioThreat-E Test
|
N/A |