← Back to all trials
Active Not Recruiting
NCT05992480
REVIVE (Response to the Ebola Virus Vaccine)
Conditions: Ebola Virus Disease
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 40
Sponsor: Tulane University
Location: Kenema Government Hospital Kenema Eastern Province
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 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.
Eligibility 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.
* \
Source: ClinicalTrials.gov (NCT05992480). StuddyBuddy aggregates publicly available trial information.
