REVIVE (Response to the Ebola Virus Vaccine)

• Register: ClinicalTrials.gov
• Last refreshed on: 24 March 2025
• Main ID: NCT05992480
• Date of registration: 07/08/2023
• Prospective Registration: Yes
• Primary sponsor: Tulane University
• Public title: REVIVE (Response to the Ebola Virus Vaccine)
• Scientific title: An Open-Label, Case-Control Study to Compare the Anamnestic Response to the Recombinant Vesicular Stomatitis Delta Glycoprotein Zaire Ebola Virus (ZEBOV) Glycoprotein (rVSVDG-ZEBOV-GP) Ebola Virus Vaccine Among Ebola Virus Disease Survivors to the Primary Immune Response Among Naïve Age and Sex-Matched Controls
• Date of first enrolment: May 2025
• Target sample size: 40
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05992480
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Sierra Leone

Contacts

• Name: John Schieffelin, MD
• Affiliation: Tulane University

• Name: Robert Samuels, MBChB

• Name: John Schieffelin, MD

Key inclusion & exclusion 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.


Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ebola Virus Disease

Intervention(s)

Biological: rVSVDG-ZEBOV-GP Ebola Virus Vaccine (ERVEBO)

Primary Outcome(s)

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 [Time Frame: 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 [Time Frame: 6 months]

Secondary Outcome(s)

Assess the phenotype, function, and durability of EBOV specific T-cell responses in natural immunity (EVD survivors) and response to vaccination with rVSVDG-ZEBOV-GP in EVD survivors and naïve vaccinees [Time Frame: 6 months]

Assess the durability of neutralizing antibody titers after immunization with rVSVDG-ZEBOV-GP among EVD survivors compared with unexposed age- and sex-matched controls at six months post-vaccination [Time Frame: 6 months]

Determine Fc-mediated innate effector function profiles in EVD survivors compared to both naïve vaccinees and EVD survivors vaccinated with rVSVDG-ZEBOV-GP. [Time Frame: 6 months]

Secondary ID(s)

2023-970

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme LLC

Kenema Government Hospital