Ebola Vaccine Registry
Research type
Research Study
Full title
A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
IRAS ID
202965
Contact name
Matthew Snape
Contact email
Sponsor organisation
Crucell Holland B.V
Eudract number
2015-004139-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
Summary of Research
The current outbreak of Ebola Virus Disease (EVD) in West Africa has caused an estimated 25,000 cases and 10,000 deaths. There is no licensed vaccine nor any specific treatment available. The development of an effective Ebola vaccine could prove an invaluable tool for control of future outbreaks.
Currently two candidate vaccines against Ebola (Ad26.ZEBOV and MVA-BN®-Filo) are being evaluated in Phase 1, 2, and 3 clinical studies in different immunisation schedules. These vaccines have been given as part of an immunisation schedule according to a 'prime-boost' approach, i.e. participants will receive one study vaccine to prime an ebolavirus-specific immune response followed by another study vaccine to boost the immune response at different time points.
The safety profile of Ad26.ZEBOV and MVA-BN-Filo needs to be established through monitoring of safety data for periods longer than those that are available from the Phase 1, 2 and 3 clinical studies. By extending the follow-up serious adverse events not detected during the initial follow-up period in the vaccine clinical studies may be identified.
This is a multi-country, prospective, long-term clinical safety study designed to extend the total follow-up period of vaccinated subjects up to 60 months (including the duration in the subject’s original study), to allow collection of serious adverse events and pregnancy outcomes following administration of Ad26.ZEBOV and/or MVA-BN-Filo among subjects who participated in a Phase 1, 2 or 3 clinical study. In addition serious adverse event information that occur in any children born to female subjects will be collected for 60 months after birth
The study will consist of an enrolment visit, a number of follow-up contacts (preferably contacted by telephone) and an end of study visit. The study will take place at the Oxford Vaccine Group, University of Oxford. The study is sponsored by Crucell Holland B.V. and is supported by a grant from the Innovative Medicines Initiative.
Summary of Final Report
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REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0227
Date of REC Opinion
1 Jun 2016
REC opinion
Further Information Favourable Opinion