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

NCT02661464 | Terminated Phase 3 Results FDA Drug

• 3 other identifiers: CR1081122015-004139-11VAC52150EBL4001
• Study Type: interventional
• Target: 677
• Locations: 7 countries
• Sites: 16

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 60 months

Study Arms (1)

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).

Biological: Ad26.ZEBOV; Biological: MVA-BN-Filo

Interventions

Ad26.ZEBOV BIOLOGICAL

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.

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

MVA-BN-Filo BIOLOGICAL

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.

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

Eligibility Criteria

• Age: 0 Years - 71 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead
• Bavarian Nordic: collaborator

Study Sites (16)

Unknown Facility

Rockville, Maryland, United States

Location

Unknown Facility

BoboDioulasso, Burkina Faso

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Unknown Facility

Ouagadougou, Burkina Faso

Location

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Créteil, France

Location

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Paris, France

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Pierre-Bénite, France

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Rennes, France

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Saint-Etienne, France

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Strasbourg, France

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Tours, France

Location

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Nairobi, Kenya

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Mwanza, Tanzania

Location

Unknown Facility

Entebbe, Uganda

Location

Unknown Facility

Kampala, Uganda

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Oxford, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38400193 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Limitations and Caveats

As none of the participants met Cohort 2 eligibility criteria pre-specified in the protocol, therefore no participants were enrolled in Cohort 2. So the results were only presented for Cohorts 1 and 3.

Results Point of Contact

• Title: Medical Leader
• Organization: Janssen Vaccines & Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 22, 2016
• Study Start: May 31, 2016
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: January 2, 2024
• Results First Posted: January 2, 2024

Record last verified: 2023-12

Locations

US (1); FR (7); TA (1); KE (1); UG (2); BU (2); GB (2)