REVIVE (Response to the Ebola Virus Vaccine)

NCT05992480 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 2023-970
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ebola Virus Disease

Keywords

Vaccine; Ebola; Sierra Leone; Ebola survivor

Outcome Measures

Primary Outcomes (2)

• 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

  Serum samples will be tested for the presence of anti-EBOV GP immunoglobulin G (IgG) and anti-EBOV Viral Protein 40 (VP40) IgG using ELISA plates produced by Zalgen Labs, LLC and run according to the manufacturer's instructions.

  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

  The investigators will assess the following adverse events at all post-vaccination follow-up time points: arthralgia, diarrhea, fatigue, fever, headache, induration, injection site pain, muscle pain, myalgia, and vomiting. Follow up visits will occur on days 1, 3, 7, 14, 28, 90 and 180 post vaccination.

  6 months

Secondary Outcomes (3)

• 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

  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.

  6 months

• 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

  6 months

Study Arms (2)

Ebola Virus Disease (EVD) survivors

EXPERIMENTAL

Participants with a history of admission and discharge from an Ebola Treatment Unit as registered by the Sierra Leone Association of Ebola Survivors (SLAES), and Anti-EBOV GP IgG positive by ELISA at the time of screening.

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

Community control

ACTIVE COMPARATOR

Age- and sex-matched controls who are Anti-EBOV GP IgG negative by ELISA at the time of screening.

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

Interventions

rVSVDG-ZEBOV-GP Ebola Virus Vaccine (ERVEBO) BIOLOGICAL

It is an Ebola virus vaccine

Community control; Ebola Virus Disease (EVD) survivors

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kenema Government Hospital: collaborator
• Tulane University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Kenema Government Hospital

Kenema, Eastern Province, Sierra Leone

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• John Schieffelin, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 survivor to control

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From preliminary interim analysis until the final report of the study, the site owns the data and it is agreed that publication will occur in a timely manner.
• Access Criteria: All files and source documents will be kept confidentially in locked, fireproof safety cabinets with limited access. The Principal Investigator, co-investigators, and clinical research staff will have access to records. The investigators will permit authorized representatives of the sponsor, regulatory agencies, and monitors to examine (and when required by applicable law, to copy) clinical records for the purposes of quality assurance reviews, audits, and evaluation of the study safety and progress.

Locations

SI (1)