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

Hemorrhagic Fever, Ebola Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02967003
• Other study ID #: CR108112
• Secondary ID: 2015-004139-11VA
• Status: Recruiting
• Phase: Phase 3
• First received: October 28, 2016
• Last updated: November 15, 2016
• Start date: May 2016
• Est. completion date: May 2022

Study information

• Verified date: November 2016
• Source: Janssen Vaccines & Prevention B.V.
• Contact: Use link at the bottom of the page to see if you qualify for an
• Email: JNJ.CT[@]sylogent.com
• Is FDA regulated: No
• Health authority: Cote dIvoire: National Research and Ethics CommitteeFrance: Agence Nationale de Sécurité du Médicament et des produits de santéMozambique: Ministry of Health (MISAU)Great Britain: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationTanzania: Food & Drug AdministrationSierra Leone: Ministry of Health and SanitationBurkina Faso: Ministry of HealthKenya: Ministry of HealthUganda: Ministry of HealthNigeria: The National Agency for Food and Drug Administration and Control
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5500
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 71 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhagic Fever, Ebola

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Vaccines & Prevention B.V.	Bavarian Nordic GmbH

Countries where clinical trial is conducted

United States,  Burkina Faso,  Côte D'Ivoire,  France,  Kenya,  Mozambique,  Nigeria,  Sierra Leone,  Tanzania,  Uganda,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Serious Adverse Events (SAEs)		up to 60 months after prime vaccination (including the duration in the participants original study)	Yes
Primary	Percentage of pregnancies with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV		up to 3 months after vaccination	Yes
Primary	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		up to 3 months after vaccination	Yes
Primary	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		up to 3 months after vaccination	Yes
Primary	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		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)	Yes

External Links

•   To learn how to participate in this trial please click here.