REVIVE — how the ERVEBO® vaccine boosts immune memory in Ebola survivors
An Open-Label, Case-Control Study to Compare the Anamnestic Response to the Recombinant Vesicular Stomatitis Delta Glycoprotein Zaire Ebola Virus (ZEBOV) Glycoprotein (rVSVDG-ZEBOV-GP) Ebola Virus Vaccine Among Ebola Virus Disease Survivors to the Primary Immune Response Among Naïve Age and Sex-Matched Controls
This project will see if a dose of ERVEBO® boosts immune protection in Ebola survivors compared with age- and sex‑matched adults who were not infected.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Locations | 1 site (Kenema, Eastern Province) |
| Trial ID | NCT05992480 on ClinicalTrials.gov |
What this trial studies
REVIVE is an open‑label, case‑control Phase 4 pilot in Kenema that gives a single dose of the rVSVDG‑ZEBOV‑GP (ERVEBO®) vaccine to registered Ebola survivors and to age‑ and sex‑matched antibody‑negative controls and follows them for safety and immune responses. Investigators will collect multiple blood samples over about six months to measure anti‑EBOV GP IgG and other immunologic markers, and will record any adverse events. The main hypothesis is that survivors will show a non‑inferior anamnestic immune response compared with matched unexposed adults. The project is led by Tulane University in collaboration with Kenema Government Hospital and funded by Merck.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years and >45.5 kg) who are either registered Ebola survivors with positive anti‑EBOV GP IgG and willing to receive ERVEBO® and serial blood draws, or age‑ and sex‑matched uninfected adults who test antibody‑negative and agree to the same procedures.
Not a fit: People who have already received the ERVEBO® vaccine, are currently in another vaccine trial, or received a live vaccine within four weeks of screening may not benefit from participating.
Why it matters
Potential benefit: If successful, the results could show that vaccinating survivors boosts antibody levels and help guide revaccination policies to reduce recurrence and onward transmission.
How similar studies have performed: ERVEBO® produced protective immune responses in large West African trials (including STRIVE) and led to regulatory approvals, though using it specifically to test anamnestic responses in survivors is a focused pilot approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * EVD survivors * History of admission and discharge from an Ebola Treatment Unit as registered by the Sierra Leone Association of Ebola Survivors (SLAES). * Anti-EBOV GP IgG positive by ELISA at the time of screening. * ≥18 years of age. * \>45.5 kg (100lbs). * Willingness to provide informed, written consent. * Willingness to undergo all study procedures including rVSVDG-ZEBOV-GP vaccination and multiple blood collections over a period of six months. * Age- and sex-matched controls * Anti-EBOV GP IgG negative by ELISA at the time of screening. * ≥18 years of age. * Willingness to provide informed consent. * Willingness to undergo all study procedures including rVSVDG-ZEBOV-GP vaccination and multiple blood collections over a period of six months. Exclusion Criteria: * Have received the rVSVDG-ZEBOV-GP vaccine. * Currently participating in another clinical trial involving a vaccine. * Received a live vaccine within four weeks of screening. * \<18 years of age. * Weight \<45.5kg (or 100 lbs). * Refusal to provide informed, written consent. * Prisoners of other institutionalized individuals. * Research study staff and their immediate family members. * Inability to participate in research activities. * Pregnant and lactating females. * Known immunocompromised status. * Known allergy to vaccine components.
Where this trial is running
Kenema, Eastern Province
- Kenema Government Hospital — Kenema, Eastern Province, Sierra Leone (Recruiting)
Study contacts
- Principal investigator: John Schieffelin, MD — Tulane University
- Study coordinator: John Schieffelin, MD
- Email: jschieff@tulane.edu
- Phone: 504-988-5117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.