Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

Last updated: November 15, 2016
Sponsor: Janssen Vaccines & Prevention B.V.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02967003
CR108112
VAC52150EBL4001
2015-004139-11
  • Ages < 71
  • Both
  • Accepts Healthy Volunteers

Study Summary

The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female who participated in a Phase 1, 2 or 3 clinical study with Humanadenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV) and/or Modified Vaccinia Virus Ankara ‐ Bavarian Nordic Filo‐vector (MVA-BN-Filo) and has been exposed to Ad26.ZEBOV and/or MVA-BN-Filo (Cohort 1)

  • Female who participated in a Phase 1, 2 or 3 clinical study with Ad26.ZEBOV and/orMVA-BN-Filo and became pregnant with estimated conception within 28 days aftervaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV (Cohort 2)

  • Child born to female participants exposed to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 clinical study who became pregnant with estimated conception within 28days after vaccination with MVA-BN-Filo or within 3 months after vaccination withAd26.ZEBOV (Cohort 3)

  • Must sign an informed consent form for the current study (or their legally acceptablerepresentative must sign) indicating that he or she understands the purpose of, andprocedures required for, the study and is willing to participate in the study (or lettheir child participate); Assent is also required of children capable ofunderstanding the nature of the study (typically 7 years of age and older)

Exclusion

Exclusion Criteria:

  • No exclusions beyond those that are not meeting the inclusion criteria

Study Design

Total Participants: 5500
Study Start date:
May 01, 2016
Estimated Completion Date:
May 31, 2022

Study Description

This is a multi-country, prospective, long-term clinical safety study for collection of serious adverse events and pregnancy outcomes following administration of Ad26.ZEBOV and/or MVA-BN-Filo vaccines among participants who were enrolled in Phase 1, 2 or 3 clinical studies. The safety data will be collected in 3 cohorts; Cohort 1- adult and pediatric participants that received Ad26.ZEBOV and/or MVA-BN-Filo in Phase 1, 2 or 3 clinical studies (adults, adolescents and children), Cohort 2- Female participants who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV will be followed to the end of their pregnancy for pregnancy outcomes (Cohort 2). After the end of pregnancy, female participants will continue to be followed in Cohort 1. Cohort 3 - children born to female participants exposed to Ad26.ZEBOV and/or MVA-BN-Filo who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV. Safety data will be collected on all consenting participants.

Connect with a study center

  • Bobodioulasso,
    Burkina Faso

    Site Not Available

  • Ouagadougou,
    Burkina Faso

    Site Not Available

  • Abidjan,
    Côte D'Ivoire

    Site Not Available

  • Toupah/Ousrou,
    Côte D'Ivoire

    Site Not Available

  • Créteil,
    France

    Site Not Available

  • Marseille,
    France

    Site Not Available

  • Paris,
    France

    Site Not Available

  • Pierre Benite,
    France

    Site Not Available

  • Rennes,
    France

    Site Not Available

  • Saint Etienne,
    France

    Site Not Available

  • Strasbourg,
    France

    Site Not Available

  • Tours,
    France

    Site Not Available

  • Kericho,
    Kenya

    Site Not Available

  • Nairobi,
    Kenya

    Active - Recruiting

  • Maputo,
    Mozambique

    Site Not Available

  • Abuja,
    Nigeria

    Site Not Available

  • Kambia,
    Sierra Leone

    Site Not Available

  • Rokupr,
    Sierra Leone

    Site Not Available

  • Mbeya,
    Tanzania

    Site Not Available

  • Mwanza,
    Tanzania

    Site Not Available

  • Entebbe,
    Uganda

    Site Not Available

  • Kampala,
    Uganda

    Site Not Available

  • London,
    United Kingdom

    Site Not Available

  • Oxford,
    United Kingdom

    Active - Recruiting

  • Southampton,
    United Kingdom

    Site Not Available

  • Rockville, Maryland
    United States

    Site Not Available

  • Silver Spring, Maryland
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.