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Providing Additional Information on the Safety and Effectiveness of an Ebola Vaccine

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ClinicalTrials.gov Identifier: NCT03161366
Recruitment Status : Completed
First Posted : May 19, 2017
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
Medecins Sans Frontieres, Netherlands
Information provided by (Responsible Party):
Epicentre

Tracking Information
First Submitted Date  ICMJE May 18, 2017
First Posted Date  ICMJE May 19, 2017
Last Update Posted Date December 19, 2018
Actual Study Start Date  ICMJE May 28, 2018
Actual Primary Completion Date July 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
Cumulative incidence [ Time Frame: 84 days after vaccination ]
Occurrence of Ebola Zaire cases amongst contacts and contacts of contacts
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
Assessment of Adverse and Serious Adverse Events [ Time Frame: 84 days after vaccination ]
Safety of a single dose of rVSVΔG-ZEBOV-GP
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Providing Additional Information on the Safety and Effectiveness of an Ebola Vaccine
Official Title  ICMJE An Open-label, Single Arm Study to Provide Additional Information on Safety and Effectiveness of rVSVΔG-ZEBOV-GP
Brief Summary Interventional, single arm, open-label, non-randomized, phase IIIb study to accumulate additional data on safety and effectiveness of one dose of rVSVΔG-ZEBOV-GP against Ebola virus disease.
Detailed Description

Ebola Virus Disease remains ill-known by populations, creating fear and mistrust, is highly contagious, requiring strict isolation measures and with only supportive therapy available that has limited impact on case-fatality which remains high (30 -80%).1 Among vaccines in development, the rVSVΔG-ZEBOV-GP vaccine has given the most promising results in terms of efficacy and safety having been evaluated now in more than 10,000 individuals.

Ring vaccination is a known strategy to control epidemics with specific transmission chains and has been successfully implemented to eradicate smallpox. Ring vaccination enhances standard public health measures of contact tracing, isolation, and community engagement and could be effective when such measures are in place. Building on the interim results of the Ebola ça Suffit trial, there is a need for continued access to a vaccine of which available results suggest that it is safe and likely efficacious against EVD. Although only isolated cases have been reported in Guinea, Sierra Leone and Liberia in 2016, 10 the risk of resurgence or of continued isolated cases in West Africa remains. Moreover, a new outbreak with Ebola Zaïre could start any moment in any of the countries where previous outbreaks occurred as in for example Democratic Republic of Congo and Uganda.

However, the unusual design of the ring trial and the decision to abandon the control group because of strong evidence that the vaccine prevented disease means there may not be enough data to ensure approval from regulatory agencies. Therefore, additional information is still required to consolidate knowledge on the rVSVΔG-ZEBOV-GP vaccine to support regulatory approval and licensure for future access. Additional information is also needed on ring vaccination and contextual adaptations to this approach to ensure its feasibility and effectiveness in the control of Ebola outbreaks in potentially diverse contexts.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Interventional, single arm, open-label, non-randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Ebola Virus Disease
Intervention  ICMJE Biological: rVSVΔG-ZEBOV-GP
Ring vaccination with vaccination of contacts and contacts of contacts after laboratory confirmation of one Ebola Zaire case
Study Arms  ICMJE Experimental: Single arm
Vaccination of contacts and contacts of contacts of a confirmed Ebola Zaire case with one dose of rVSVΔG-ZEBOV-GP (≥ 2x10^7 PFU)
Intervention: Biological: rVSVΔG-ZEBOV-GP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2017)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2018
Actual Primary Completion Date July 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals aged 6 years or older will be enrolled in the study if they are a contact or contact of contact of a laboratory-confirmed Ebola virus disease case. Children aged between 1 and 6 years may also be enrolled in the study in case there is a confirmed contact with a laboratory-confirmed Ebola patient
  • willing to accept weekly visits
  • intending to remain in the study area for three months
  • providing informed consent, and where applicable, assent

Exclusion Criteria:

  • history of EVD (self-report or laboratory confirmed)
  • history of having received other investigational research agents in the previous 28 days
  • history of anaphylaxis to a vaccine or vaccine component (self-report)
  • severe illness that makes the person bed-bound or requiring hospitalization at the time of the vaccination
  • severe immunocompromised status
  • history of having received immunosuppressant therapies that would substantially interfere with the mode of action of the Ebola vaccine in the previous 6 months
  • unwilling to accept weekly visits
  • not intending to remain in the study area for three months
  • informed consent or assent not provided
  • any other condition in which, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence, or impair the subject or caregiver's ability to give informed consent, and where applicable, assent.
  • fever above 38°C
  • previous receipt of rVSVΔG-ZEBOV-GP in the last 3 years or at being part of another Ebola vaccine clinical trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Congo, The Democratic Republic of the,   Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03161366
Other Study ID Numbers  ICMJE V920-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: To be done following MSFdata sharing policy
Responsible Party Epicentre
Study Sponsor  ICMJE Epicentre
Collaborators  ICMJE Medecins Sans Frontieres, Netherlands
Investigators  ICMJE Not Provided
PRS Account Epicentre
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP