Status:
COMPLETED
EBOVAC-Salone Extension
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
University of Sierra Leone
Janssen Vaccines & Prevention B.V.
Conditions:
Ebola Virus Disease
Eligibility:
All Genders
1+ years
Brief Summary
The VAC52150EBL3005 (EBOVAC-Salone Extension) is a cohort study evaluating the long-term safety and immunogenicity of the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo in participants who were ...
Detailed Description
The VAC52150EBL3005 (EBOVAC-Salone Extension) is a cohort study to evaluate the long-term safety and immunogenicity of the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo in adults and children. ...
Eligibility Criteria
Inclusion
- Must be a participant, or former participant, of the EBOVAC-Salone study, and received Ebola vaccine prime vaccination.
- or Must be an infant conceived by a female participant of EBOVAC-Salone during the 3-month period following vaccination with Ad26.ZEBOV or the 28 day period following vaccination with MVA-BN®-Filo.
- Must consent to participate in the EBOVAC-Salone Extension study by signing (or thumbprinting, if illiterate) an ICF, indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. If a potential participant cannot read or write, the procedures must be explained and informed consent must be witnessed by a literate third party not involved in the conduct of the study. If the potential participant is under 18 years of age, they and their parent/guardian will be informed about the study and the parent/guardian will be asked to give consent. Children aged 7 years and older will be asked to give positive assent for their participation in the study and the assent procedure must be witnessed by an adult, literate parent/guardian/third party not involved in the conduct of the study, and documented.
- Must confirm that he/she will return to the study site for each yearly visit.
Exclusion
- Participants in the EBOVAC-Salone study who were allocated to the control arm receiving the WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine
- Subjects who, in the opinion of the investigator, are unlikely to adhere to the requirements of the study, or unlikely to complete follow up
Key Trial Info
Start Date :
July 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 14 2022
Estimated Enrollment :
653 Patients enrolled
Trial Details
Trial ID
NCT03820739
Start Date
July 22 2019
End Date
July 14 2022
Last Update
February 8 2023
Active Locations (2)
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1
EBOVAC Rokupr clinic
Rokupr, Kambia, Sierra Leone
2
EBOVAC Kambia 1 clinic
Kambia, Sierra Leone