Re-evaluating Optimal Vaccine Schedules Against Ebola (REVOLVE)
Research type
Research Study
Full title
Evaluating the Long Term Immunogenicity of Ad / MVA Ebola Virus Vaccines following late boosting with AD26.ZEBOV vaccine administered after heterologous prime/boost schedules of adenoviral and MVA vectored Ebola vaccines: an open-label clinical trial
IRAS ID
237494
Contact name
Matthew Snape
Contact email
Sponsor organisation
Clinical Trials and Research Governance (CTRG), University of Oxford
Eudract number
2017-004610-26
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
This study will evaluate the duration of the immune response of a late booster dose of a vaccine against Ebola Virus Disease (EVD), AD26.ZEBOV, in healthy adults previously immunised with investigational Ebola vaccine schedules. This will generate data crucial to the understanding of persistence of immunity after initial immunisation, and whether a late booster dose confers additional benefit in long term persistence of immunity. These data are critical in informing the potential for the investigational vaccines schedules to provide sustained immunity to those at ongoing risk of EVD (e.g. health care workers) and whether this can be significantly altered by the additional dose of AD26.ZEBOV.
To achieve this, participants who have completed previous Phase 1 and 2 Ebola vaccine studies in the UK including EBL01 (REC 14/SC/1256), EBL04 (REC 15/SC/0108) and EBL05 (REC 15/SC/0267) led by the Oxford Vaccine Centre, will be invited to participate in these ‘follow-on’ studies, in which blood tests will be taken at 2 to 5 years after initial immunisation. Participants who are willing to take part in the follow-on study will be invited to receive a booster dose of AD26.ZEBOV, but this is not a requirement of participation. Blood tests will be taken one month after Ad26.ZEBOV in those receiving the booster dose with this vaccine. All participants having a further blood test at one year after enrollment, allowing us to evaluate the persistence of vaccine induced immunity with and without a late booster dose of Ad26.ZEBOV. Antibody and cellular immune response will be evaluated at laboratories in Oxford.
This study will recruit at the Oxford Vaccine Group and at the clinical research facility, Imperial College. The study is funded by Innovate UK.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0399
Date of REC Opinion
25 Sep 2018
REC opinion
Further Information Favourable Opinion