Actively Recruiting
REVIVE (Response to the Ebola Virus Vaccine)
Led by Tulane University · Updated on 2025-12-23
40
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
T
Tulane University
Lead Sponsor
K
Kenema Government Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 School of Medicine. This study is funded by Merck \& Co., the developers of ERVEBO®. This investigational medicinal product (IMP) was successful in Sierra Leone through the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) working with the College of Medical and Allied Health Services (COMAHS) at the University of Sierra Leone. ERVEBO® was also successfully tested in Liberia and the Republic of Guinea. These successful trials led to the United States Food and Drug Administration (USFDA) approval of ERVEBO®, as well as approval for therapeutic use in the Democratic Republic of the Congo, Burundi, Ghana, and Zambia. This particular vaccination study will focus on the anamnestic response to the ERVEBO® vaccine, (full name - rVSVDG-ZEBOV-GP Ebola Virus Vaccine). The original clinical trials conducted excluded Ebola Virus Disease (EVD) survivors from participating. However, with ongoing research, there is evidence of waning immune response and even recurrent infections in EVD survivors.
CONDITIONS
Official Title
REVIVE (Response to the Ebola Virus Vaccine)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- EVD survivors with documented admission and discharge from an Ebola Treatment Unit as registered by the Sierra Leone Association of Ebola Survivors (SLAES)
- Positive Anti-EBOV GP IgG antibody test by ELISA at screening for EVD survivors
- Age 18 years or older
- Weight greater than 45.5 kg (100 lbs)
- Willingness to provide informed, written consent
- Willingness to undergo vaccination and multiple blood draws over six months
- Age- and sex-matched controls who are Anti-EBOV GP IgG negative by ELISA at screening
- Willingness to provide informed consent and participate in all study procedures including vaccination and blood collections
You will not qualify if you...
- Prior receipt of the rVSVDG-ZEBOV-GP vaccine
- Current participation in another vaccine clinical trial
- Receipt of any live vaccine within four weeks before screening
- Age under 18 years
- Weight less than 45.5 kg (100 lbs)
- Refusal to provide informed, written consent
- Prisoners or other institutionalized individuals
- Research staff or immediate family members
- Inability to participate in research activities
- Pregnant or lactating females
- Known immunocompromised status
- Known allergy to vaccine components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kenema Government Hospital
Kenema, Eastern Province, Sierra Leone
Actively Recruiting
Research Team
J
John Schieffelin, MD
CONTACT
N
Nell Bond, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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