Overview

This trial is active, not recruiting.

Condition hemorrhagic fever, ebola
Treatment rvsvΔg-zebov
Phase phase 2/phase 3
Sponsor Centers for Disease Control and Prevention
Collaborator University of Sierra Leone
Start date April 2015
End date December 2016
Trial size 8000 participants
Trial identifier NCT02378753, CDC-NCIRD-6689

Summary

The 2014 outbreak of Ebola in West Africa is the largest in recorded history with widespread and intense transmission in Guinea, Liberia, and Sierra Leone. The high infectivity of blood and secretions, lack of appropriate personal protective equipment (PPE) and challenges in following infection control and prevention protocols put healthcare workers at high risk during outbreaks, and direct contact with the bodies of deceased Ebola victims can also sustain community transmission. This study will accelerate introduction and use of monovalent recombinant vesicular stomatitis virus Ebola vaccine (rVSVΔG-ZEBOV) among healthcare workers and frontline personnel involved in the Ebola outbreak response in Sierra Leone, while concurrently evaluating the safety and efficacy of the vaccine.

This is an unblinded, randomized trial with phased vaccine introduction in the target population. Participation in the study will be voluntary and open to adults 18 years of age and older who are at high risk of exposure to Ebola infection through their daily work and who work in a selected study area.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)
rvsvΔg-zebov BPSC-1001
The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain).
(Experimental)
One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) in participants randomized to receive deferred vaccination (18-24 weeks after enrollment).
rvsvΔg-zebov BPSC-1001
The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain).

Primary Outcomes

Measure
Laboratory-confirmed Ebola (study diagnostics)
time frame: > 21 days following vaccination
Occurrence of Serious Adverse Events during the 6 months following the vaccination
time frame: 6 months following vaccination

Secondary Outcomes

Measure
Death due to laboratory-confirmed Ebola
time frame: 6 months following vaccination
Ebola confirmed by non-study or study diagnostics
time frame: 6 months following vaccination
Suspected, probable or laboratory-confirmed Ebola
time frame: 6 months following vaccination
Occurrence of solicited injection-site and systemic reactogenicity signs and symptoms, including fever, on vaccination day and during the 7 days following the vaccination.
time frame: Vaccination day and for 7 days following vaccination
Occurrence of solicited and unsolicited AEs during the 28 days following the vaccination
time frame: During 28 days following vaccination
Collect and store serum for immunogenicity evaluations and assessment of baseline Ebola IgG antibody levels among a subset of study participants.
time frame: 12 months following vaccination

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Age 18 years or older. 2. Member of target population at the time of enrollment: - active worker in an Ebola care, holding, or treatment center (may include physicians, nurses, nurse aides, lab technicians, pharmacists, pharmacy technicians, cleaners, and security and administrative staff); - active worker in a facility providing non-Ebola-related healthcare (may include physicians, nurses, nurse aides, lab technicians, pharmacists, pharmacy technicians, cleaners, and security and administrative staff); - active frontline worker in one of the following job categories: surveillance team, ambulance team, burial worker, or worker responsible for swabbing deceased persons. 3. Reasonably anticipates living in Sierra Leone for the 18-24 weeks following enrollment. 4. Reachable by phone throughout the 6 month post-vaccination safety follow-up period. 5. Willing to adhere to personal protective equipment (PPE) and infection control recommendations. 6. Able and willing to complete the informed consent process and study procedures. 7. Willing to receive vaccine in either the immediate or the deferred trial arms, according to random assignment. Exclusion Criteria: 1. History of Ebola (self-report). 2. Prior receipt of experimental Ebola or Marburg vaccine. 3. History of human immunodeficiency virus (HIV) or clinically important immunodeficiency (self-report). 4. Any history of allergy or anaphylaxis to prior vaccines 5. Breast-feeding an infant or child. 6. Any reason the investigator suspects that data collected from this person would be incomplete or of poor quality. 7. Current pregnancy (a negative urine pregnancy test is required for women participants <50 years of age who self-report as not pregnant). 8. Currently being followed for known exposure to Ebola. 9. Known experimental research agents or other vaccine within 28 days (4 weeks) before vaccination. 10. Fever ≥ 38.0°C (100.4°F) at time of vaccination.

Additional Information

Official title [rVSVΔG-ZEBOV] Ebola Prevention Vaccine Evaluation in Sierra Leone
Principal investigator Mohamed Samai, MBChB,PhD
Description The Ebola outbreak was confirmed in March 2014 with widespread and intense transmission in Guinea, Liberia, and Sierra Leone. While there are no U.S. Food and Drug Administration (FDA)-approved pharmaceuticals to prevent or treat Ebola, two candidate vaccines are being tested in humans for dosing, tolerability, and safety. This study will evaluate monovalent recombinant vesicular stomatitis virus Ebola vaccine that remains replication competent (rVSVΔG-ZEBOV) in Sierra Leone. The high infectivity of blood and secretions, lack of appropriate personal protective equipment (PPE) and challenges in following infection control and prevention protocols put healthcare workers at high risk during outbreaks, and direct contact with the bodies of deceased Ebola victims can also sustain community transmission. This unblinded, randomized trial will evaluate vaccine efficacy (VE) and safety with phased vaccine introduction in the target population. Participation in the study will be voluntary and open to adults 18 years of age and older who are at high risk of exposure to Ebola infection through their daily work and who work in a selected study area. This includes: 1) personnel working in healthcare facilities where care is provided for Ebola patients; 2) personnel working in non-Ebola healthcare facilities who may have exposure to undiagnosed Ebola-infected individuals; and 3) personnel working in one of the following job categories: surveillance team, ambulance team, or laboratory worker responsible for swabbing deceased persons. Staff members involved in this study are also eligible to receive the vaccine under this protocol; study staff will be followed for 6 months post-vaccination to monitor for safety of rVSVΔG-ZEBOV. Eligible participants within a healthcare facility or frontline team will be enrolled and individually randomized to either immediate or deferred vaccination. A single dose of rVSVΔG-ZEBOV will be administered intramuscularly. Immediate vaccination is defined as vaccination within 7 days of enrollment and deferred vaccination is defined as vaccination at the end of an 18-24 week follow-up period. Participants will not be blinded to the randomized assignment of immediate or deferred vaccination. All enrolled participants will have the opportunity to receive rVSVΔG-ZEBOV by the end of the study. Enrollment and vaccination will be phased over time. Ebola events that occur during the 18-24 week post-enrollment will be included in the VE analysis, with the immediate vaccination arm contributing vaccinated follow-up time and the deferred vaccination arm contributing unvaccinated follow-up time. All participants, regardless of randomized assignment, will be followed for 6 months after vaccination to monitor for safety of rVSVΔG-ZEBOV.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centers for Disease Control and Prevention.