REVIVE (Response to the Ebola Virus Vaccine)

Launched by TULANE UNIVERSITY · Aug 7, 2023

Keywords

ClinConnect Summary

The REVIVE clinical trial is studying the response to the ERVEBO® Ebola vaccine, specifically looking at how well this vaccine works for people who have survived Ebola Virus Disease (EVD). The goal is to understand how the immune system reacts to the vaccine, especially since some survivors may have a weaker immune response over time. This study will take place at Kenema Government Hospital in Sierra Leone and is led by a collaboration between local researchers and Tulane University School of Medicine, with funding from Merck & Co.

To participate in this study, you would need to be at least 18 years old and either a survivor of EVD with a documented history of treatment or a matched control who has never had Ebola. Eligible participants will receive the vaccine and will need to provide blood samples over six months to monitor their response. It's important to know that those who have already received the ERVEBO® vaccine or are currently involved in other vaccine trials cannot participate. The information gained from this study could help improve future treatments and vaccines for EVD survivors.

Gender

ALL

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.
• • \<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.