A Clinical Safety Study of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

• Register: EUCTR
• Last refreshed on: 21 March 2022
• Main ID: EUCTR2015-004139-11-FR
• Date of registration: 05/05/2017
• Prospective Registration: No
• Primary sponsor: Janssen Vaccines & Prevention B.V.
• Public title: A Clinical Safety Study of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
• Scientific title: A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
• Date of first enrolment: 23/03/2017
• Target sample size: 3059
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004139-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: long term safety follow-up; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 0
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Burkina Faso, France, Ghana, Kenya, Mozambique, Nigeria, Rwanda, Tanzania, United Republic of, Uganda, United Kingdom, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen Research and Development

• Name: Clinical Registry Group
• Affiliation: Janssen Research and Development

Key inclusion & exclusion criteria

Inclusion criteria:
- Male or female who participated in a Phase 1, 2 or 3 clinical study with Ad26.ZEBOV and/or MVA-BN-Filo and has been exposed to Ad26.ZEBOV and/or MVA-BN-Filo (or placebo) (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 placebo) or within 3 months after vaccination with Ad26.ZEBOV (or placebo) (Cohort 2)
- Child born to a female participant exposed to Ad26.ZEBOV and/or MVA-BN-Filo (or placebo) 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 placebo) or within 3 months after vaccination with Ad26.ZEBOV (or placebo) (Cohort 3)
- Provide written informed consent
- Assent is also required for of children capable of understanding the nature of the study (typically 7 years of age and older)
Are the trial subjects under 18? yes
Number of subjects for this age range: 330
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2617
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112

Exclusion criteria:
No exclusion criteria beyond participants who do not meet the inclusion criteria.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Ebola
MedDRA version: 20.0 Level: PT Classification code 10014071 Term: Ebola disease System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Product Name: Ad26.Zebov
Product Code: JNJ-61210474
Pharmaceutical Form: Suspension for injection
Current Sponsor code: AD26.ZEBOV
Other descriptive name: JNJ-61210474
Concentration unit: titre titre
Concentration type: equal
Concentration number: 5 x 10 ^ 10 vp-
Current Sponsor code: AD26.ZEBOV
Other descriptive name: JNJ-61210474
Concentration unit: titre titre
Concentration type: equal
Concentration number: 1.0x10^11 vp-

Product Name: MVA-BN-Filo
Product Code: MVA-mBN226B
Pharmaceutical Form: Suspension for injection
Current Sponsor code: MVA-mBN226B
Other descriptive name: MVA-BN-FILO
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: >=1x10^8-
Current Sponsor code: MVA-mBN226B
Other descriptive name: MVA-BN-FILO
Concentration unit: log10 TCID50 log10 tissue culture infective dose 50
Concentration type: equal
Concentration number: >=1x10^8-

Primary Outcome(s)

Main Objective: • To collect serious adverse event information from subjects exposed to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 clinical study, for a total of 60 months after prime vaccination (including the duration in the subject’s original study).
• To collect pregnancy outcomes (including spontaneous/elective abortion, intrauterine death/stillbirth, information on delivery) and serious adverse event information during pregnancy from female subjects who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV in a Phase 1, 2 or 3 clinical study.
• To collect serious adverse event information for up to 60 months after birth from children born to female subjects who became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV in a Phase 1, 2 or 3 clinical study.

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: • up to 60 months after prime vaccination (including the duration in the subject´s original study).
• N/A
• N/A
• up to 60 months after birth.

Primary end point(s): • Incidence of participants with Serious Adverse Events (SAE)
• Incidence of participants who became pregnant within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV
• Incidence of live-born children from pregnancy
• Incidence 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(s)

Timepoint(s) of evaluation of this end point: -

Secondary end point(s): -

Secondary ID(s)

2015-004139-11-GB

VAC52150EBL4001

Source(s) of Monetary Support

Janssen Research & Development LLC

Janssen Vaccines & Prevention B.V.

Ethics review

Status: Approved
Approval date: 16/02/2017
Contact: