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Status:

UNKNOWN

Prophylaxis Vaccine Antibodies Ebola

Lead Sponsor:

ANRS, Emerging Infectious Diseases

Conditions:

Ebola Virus Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

* Three measures are currently being implemented to control Ebola outbreaks: * Monitoring of contacts * Isolation and treatment of sick people * Vaccination of the population in high-risk areas...

Eligibility Criteria

Inclusion

  • The inclusion criteria for the efficacy trial are:
  • Have had, within the previous 72 hours, a high-risk contact with an Ebola patient confirmed by RT-PCR;
  • Be 18 years of age or older at the time of inclusion;
  • Have no symptoms of EVD;
  • Give consent to participate in the efficacy trial;
  • Agree not to participate in any other therapeutic or vaccine study until the end of the trial follow-up.
  • The criteria for non-inclusion in the efficacy trial are:
  • Have a history of EVD (self-report);
  • Have been vaccinated with ERVEBO prior to the start of the study;
  • Have participated in another therapeutic or vaccine study within 15 days prior to inclusion.
  • Inclusion criteria for the immunology ancillary study are:
  • High Risk Arm:
  • Be included in the efficacy trial;
  • Be available for extended follow-up as specified in the protocol;
  • Specifically consent to the immunology ancillary study.
  • Control arm:
  • Be 18 years of age or older at the time of inclusion;
  • Have no symptoms of EVD;
  • Eligible for ERVEBO vaccination according to national program criteria;
  • Be available for extended follow-up as specified in the protocol;
  • Consent specifically for the ancillary immunology study.
  • The criteria for non-inclusion in the immunologic ancillary study are:
  • All efficacy trial non-inclusion criteria;
  • HIV positive;
  • Pregnant women.

Exclusion

    Key Trial Info

    Start Date :

    October 17 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    April 1 2022

    Estimated Enrollment :

    250 Patients enrolled

    Trial Details

    Trial ID

    NCT04822376

    Start Date

    October 17 2021

    End Date

    April 1 2022

    Last Update

    October 15 2021

    Active Locations (1)

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    1

    Centre de Traitement Ebola de N'Zerekore

    N'Zerekore, Guinea