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

December 14, 2023 updated by: Janssen Vaccines & Prevention B.V.

A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

677

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Maryland
      • Rockville, Maryland, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 71 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohorts 1 and 3: Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to 60 months
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Vaccines & Prevention B.V.

Collaborators

Bavarian Nordic GmbH

Investigators

  • Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2016

Primary Completion (Actual)

December 13, 2021

Study Completion (Actual)

December 13, 2021

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimated)

January 22, 2016

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108112
  • 2015-004139-11 (EudraCT Number)
  • VAC52150EBL4001 (Other Identifier: Janssen Vaccines & Prevention B.V.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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