Status:
RECRUITING
REVIVE (Response to the Ebola Virus Vaccine)
Lead Sponsor:
Tulane University
Collaborating Sponsors:
Kenema Government Hospital
Merck Sharp & Dohme LLC
Conditions:
Ebola Virus Disease
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
This study is a vaccine-related clinical trial which will be conducted by our study team at Kenema Government Hospital (KGH)'s Viral Hemorrhagic Fever Program in collaboration with Tulane University S...
Detailed Description
Ebola virus (EBOV; also known as Zaire ebolavirus, family Filoviridae) is among the most virulent infectious agents known, producing sporadic outbreaks of severe and highly lethal hemorrhagic fever in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05992480
Start Date
December 1 2025
End Date
May 1 2026
Last Update
December 23 2025
Active Locations (1)
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1
Kenema Government Hospital
Kenema, Eastern Province, Sierra Leone