Hemorrhagic Fever, EbolaPhase 3NCT02661464
Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
A Phase 3 study testing Ad26.ZEBOV and MVA-BN-Filo in people with Hemorrhagic Fever, Ebola, run by Janssen Vaccines & Prevention B.V. at 16 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 71 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhagic Fever, Ebola
- What is being tested?
- Ad26.ZEBOV and MVA-BN-Filo
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 677 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 31 May 2016to 13 Dec 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 71 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- No exclusions beyond those that are not meeting the inclusion criteria
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
France7 sites
Study site
Créteil
Study site
Paris
Study site
Pierre-Bénite
Study site
Rennes
Study site
Saint-Etienne
Study site
Strasbourg
Study site
Tours
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemorrhagic Fever, Ebola
- Being tested
- Ad26.ZEBOV, MVA-BN-Filo
- 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
- Medical subject headings
- Hemorrhagic Fever, Ebola, Hemorrhagic Fevers, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.ZEBOVBiological
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.
MVA-BN-FiloBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposed to Ad26.ZEBOV and/or MVA-BN Filo | Experimental | 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). Receives: Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohorts 1 and 3: Number of Participants With Serious Adverse Events (SAEs)
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.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study start31 May 2016
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Why it stopped: Due to the pandemic with only one participant in follow up, as the impact on the safety was determined to be negligible, the study was terminated early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhagic Fever, EbolaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 677 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bavarian Nordic
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661464
- Sponsor's protocol ID
- CR108112
- Other IDs
- 2015-004139-11, VAC52150EBL4001, 2015
- Status last verified
- Dec 2023
- First submitted
- 8 Jan 2016
- Last updated
- 2 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Puri A, Pollard AJ, Schmidt-Mutter C, Laine F, PrayGod G, Kibuuka H, Barry H, Nicolas JF, Lelievre JD, Sirima SB, Kamala B, Manno D, Watson-Jones D, Gaddah A, Keshinro B, Luhn K, Robinson C, Douoguih M; EBL4001 Study Group. Long-Term Clinical Safety of the Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: A Prospective, Multi-Country, Observational Study. Vaccines (Basel). 2024 Feb 17;12(2):210. doi: 10.3390/vaccines12020210.
PubMed 38400193
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
- ClinicalTrials.gov ID
- NCT02661464
- Acronym / sponsor ID
- CR108112
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the pandemic with only one participant in follow up, as the impact on the safety was determined to be negligible, the study was terminated early.
- Enrolment
- 677 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Collaborators
- Bavarian Nordic
- Study start
- 31 May 2016 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Posted 2 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposed to Ad26.ZEBOV and/or MVA-BN Filo | Experimental | Biological: Ad26.ZEBOV, Biological: MVA-BN-FiloSafety 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). |
Who may qualify
- Ages
- 0 to 71 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- No exclusions beyond those that are not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad26.ZEBOVNo 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 | Exposed to Ad26.ZEBOV and/or MVA-BN Filo |
| MVA-BN-FiloNo 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. | Biological | Exposed to Ad26.ZEBOV and/or MVA-BN Filo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38400193Puri A, Pollard AJ, Schmidt-Mutter C, Laine F, PrayGod G, Kibuuka H, Barry H, Nicolas JF, Lelievre JD, Sirima SB, Kamala B, Manno D, Watson-Jones D, Gaddah A, Keshinro B, Luhn K, Robinson C, Douoguih M; EBL4001 Study Group. Long-Term Clinical Safety of the Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: A Prospective, Multi-Country, Observational Study. Vaccines (Basel). 2024 Feb 17;12(2):210. doi: 10.3390/vaccines12020210.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Vaccines & Prevention B.V. Clinical Trial study director
Janssen Vaccines & Prevention B.V.
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ad26.ZEBOV and MVA-BN-Filo in people with Hemorrhagic Fever, Ebola, run by Janssen Vaccines & Prevention B.V. at 16 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, Burkina Faso, Uganda, United Kingdom, United States and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohorts 1 and 3: Number of Participants With Serious Adverse Events (SAEs) (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02661464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.