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

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ClinicalTrials.gov Identifier: NCT02661464
Recruitment Status : Active, not recruiting
First Posted : January 22, 2016
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Bavarian Nordic GmbH
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief 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.

Condition or disease Intervention/treatment Phase
Hemorrhagic Fever, Ebola Biological: Ad26.ZEBOV Biological: MVA-BN-Filo Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 677 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
Actual Study Start Date : May 31, 2016
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : January 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: Exposed to Ad26.ZEBOV and/or MVA-BN Filo
Safety Data will be collected from participants who received Ad26.ZEBOV and/or MVA-BN-Filo in Phase 1, 2 or 3 clinical studies in 6-month intervals up to 60 months after prime vaccination, including the duration in the participant's original study (Cohort 1). 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. Safety Data for live born children to female participants will be followed up to 60 months after birth (Cohort 3).
Biological: Ad26.ZEBOV
No vaccine will be administered in the current study. Safety data will be collected from participants who were previously exposed to Ad26.ZEBOV vaccine in Phase 1, 2, or 3 clinical studies up to 60 months and also safety data will be collected from live born children to female participants up to 60 months after birth.

Biological: MVA-BN-Filo
No vaccine will be administered in the current study. Safety data will be collected from participants who were previously exposed to MVA-BN-Filo vaccine in Phase 1, 2, or 3 clinical studies up to 60 months and also safety data will be collected from live born children to female participants up to 60 months after birth.




Primary Outcome Measures :
  1. Percentage of Serious Adverse Events (SAEs) [ Time Frame: up to 60 months after prime vaccination (including the duration in the participants original study) ]
  2. Percentage of pregnancies with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV [ Time Frame: up to 3 months after vaccination ]
  3. Percentage of pregnancies (with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV) by pregnancy outcome [ Time Frame: up to 3 months after vaccination ]
  4. Percentage of live-born children from a pregnancy with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV [ Time Frame: up to 3 months after vaccination ]
  5. Percentage of serious adverse events in children born from a pregnancy with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV [ Time Frame: Up to 60 months after birth in children born from an eligible pregnancy (with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 71 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female who participated in a Phase 1, 2 or 3 clinical study with Human adenovirus 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/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination 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 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV (Cohort 3)
  • Must sign an informed consent form for the current study (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study (or let their child participate); Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661464


Locations
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United States, Maryland
Rockville, Maryland, United States
Burkina Faso
BoboDioulasso, Burkina Faso
Ouagadougou, Burkina Faso
France
Créteil, France
Paris, France
Pierre Benite, France
Rennes, France
Saint Etienne, France
Strasbourg, France
Tours, France
Kenya
Nairobi, Kenya
Tanzania
Mwanza, Tanzania
Uganda
Entebbe, Uganda
Kampala, Uganda
United Kingdom
London, United Kingdom
Oxford, United Kingdom
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Bavarian Nordic GmbH
Investigators
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.

Additional Information:
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT02661464     History of Changes
Obsolete Identifiers: NCT02967003
Other Study ID Numbers: CR108112
2015-004139-11 ( EudraCT Number )
VAC52150EBL4001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Vaccines & Prevention B.V.:
Healthy
Ebola viruses
Ebola virus disease (EVD)
Filoviruses
Safety
Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)
Modified Vaccinia Virus Ankara ‐ Bavarian Nordic Filo‐vector (MVA‐BN Filo)
Hemorrhagic fever
Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Virus Diseases
Filoviridae Infections
Mononegavirales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs