RecruitingPhase 4

REVIVE (Response to the Ebola Virus Vaccine)

Sierra Leone40 participantsStarted 2025-12-01

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Assess the immunogenicity and durability of rVSVDG-ZEBOV-GP among EVD survivors compared with unexposed age- and sex-matched controls at six months post-vaccination

Timeframe: 6 months

Assess the incidence of adverse events after vaccination with rVSVDG-ZEBOV-GP among EVD survivors compared with unexposed age- and sex-matched controls

Timeframe: 6 months

Trial details

NCT IDNCT05992480

SponsorTulane University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

John Schieffelin, MD

504-988-5117 jschieff@tulane.edu

View on ClinicalTrials.gov More Ebola Virus Disease trials

Plain-language summary

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Assess the immunogenicity and durability of rVSVDG-ZEBOV-GP among EVD survivors compared with unexposed age- and sex-matched controls at six months post-vaccination

Timeframe: 6 months

Assess the incidence of adverse events after vaccination with rVSVDG-ZEBOV-GP among EVD survivors compared with unexposed age- and sex-matched controls

Timeframe: 6 months