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

Primary Purpose

Hemorrhagic Fever, Ebola

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ad26.ZEBOV
MVA-BN-Filo
Sponsored by
Janssen Vaccines & Prevention B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemorrhagic Fever, Ebola focused on measuring 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

Eligibility Criteria

0 Years - 71 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exposed to Ad26.ZEBOV and/or MVA-BN Filo

Arm Description

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).

Outcomes

Primary Outcome Measures

Percentage of Serious Adverse Events (SAEs)
Percentage of pregnancies with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV
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
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
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

Secondary Outcome Measures

Full Information

First Posted
January 8, 2016
Last Updated
December 7, 2022
Sponsor
Janssen Vaccines & Prevention B.V.
Collaborators
Bavarian Nordic GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02661464
Brief Title
Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
Official Title
A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2016 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Vaccines & Prevention B.V.
Collaborators
Bavarian Nordic GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Fever, Ebola
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
677 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposed to Ad26.ZEBOV and/or MVA-BN Filo
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
Ad26.ZEBOV
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
MVA-BN-Filo
Intervention Description
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 Measure Information:
Title
Percentage of Serious Adverse Events (SAEs)
Time Frame
up to 60 months after prime vaccination (including the duration in the participants original study)
Title
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
Title
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
Title
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
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Vaccines & Prevention B.V. Clinical Trial
Organizational Affiliation
Janssen Vaccines & Prevention B.V.
Official's Role
Study Director
Facility Information:
City
Rockville
State/Province
Maryland
Country
United States
City
BoboDioulasso
Country
Burkina Faso
City
Ouagadougou
Country
Burkina Faso
City
Créteil
Country
France
City
Paris
Country
France
City
Pierre Benite
Country
France
City
Rennes
Country
France
City
Saint Etienne
Country
France
City
Strasbourg
Country
France
City
Tours
Country
France
City
Nairobi
Country
Kenya
City
Mwanza
Country
Tanzania
City
Entebbe
Country
Uganda
City
Kampala
Country
Uganda
City
London
Country
United Kingdom
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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