Clinical Trial: STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: [rVSVΔG-ZEBOV] Ebola Prevention Vaccine Evaluation in Sierra Leone

Brief 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.


Detailed Summary:

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
Sponsor: Centers for Disease Control and Prevention

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Centers for Disease Control and Prevention

Dates:
Date Received: February 19, 2015
Date Started: April 2015
Date Completion:
Last Updated: April 5, 2017
Last Verified: July 2016