Evaluating Optimal Vaccine schedules against Ebola (EVOLVE)
Research type
Research Study
Full title
A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults in Europe
IRAS ID
179432
Contact name
Andrew J Pollard
Contact email
Sponsor organisation
Crucell Holland B.V
Eudract number
2015-000596-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 15 days
Research summary
The current outbreak of Ebola Virus Disease (EVD) in West Africa has caused an estimated 25,000 cases and 10,000 deaths. EVD is a highly lethal pathogen causing haemorrhagic fever with a case fatality rate of 25% to 90%. 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 this outbreak as well as any future outbreak.
This is a study looking at the safety and tolerability of two candidate vaccines against Ebola (Ad26.ZEBOV and MVA-BN®-Filo) when given by intramuscular injection to healthy adult volunteers. These vaccines will be given as part of an immunisation schedule according to a 'prime-boost' approach, i.e. participants will receive one study vaccine (Ad26.ZEBOV) to prime an ebolavirus-specific immune response followed by another study vaccine (MVA-BN-Filo) to boost the immune response 28, 56 or 84 days later. Adults aged 18 to 65 years will be invited to participate in this study. Eligible volunteers will be immunised and monitored to assess the safety profile of these vaccines by symptom reporting, blood monitoring and medical review. Immune responses to the vaccine schedules will also be assessed in detail. Some participants will be allocated to receive placebo (saline water) rather than the investigational vaccines to act as a comparator. Neither the participants nor the observing study team will be aware of this vaccine allocation during initial assessments.
The study will take place at the Oxford Vaccine Group, University of Oxford. Participants will be required to attend a maximum of 15 visits over the course of one year. The study is sponsored by Crucell Holland B.V. and is supported by a grant from the Innovative Medicines Initiative.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0211
Date of REC Opinion
18 May 2015
REC opinion
Further Information Favourable Opinion