MVAZIKB001
Research type
Research Study
Full title
A First in Person Trial of a Modified Vaccina Ankara vectored anti Zika vaccine MVAZIKB administered on two occasions 28 days apart at dose levels of 5x107 and 1x108 plaque forming units in healthy adults
IRAS ID
1005626
Contact name
Richard FitzGerald
Contact email
Sponsor organisation
University of Liverpool
Eudract number
2021-005868-21
ISRCTN Number
ISRCTN13726895
Research summary
Zika virus is a mosquito transmitted virus with some cases causing serious damage to the unborn child of a mother that is infected in the first three months of pregnancy. More rarely, Zika Virus an cause problems with nerves, called Guillain Barré syndrome, or inflammation of the brain, called encephalitis. There are currently no treatments for any of the illnesses, which can cause lasting brain damage. Therefore we want to develop a vaccine to prevent these illnesses from occurring.
MVAZIKB001 is a new vaccine that has not yet been tested in people but has in animals to show that it can create an immune response against the Zika virus. The purpose of this study is to test the safety of the vaccine and to determine the right dose that can given safely.
The study is designed to be undertaken in two seamless stages including; Stage 1, Dose escalation study to assess safety of the vaccine following by Stage 2, which is the dose expansion stage to evaluate vaccine activity. This study will recruit healthy volunteers who are very unlikely to have been exposed to Zika virus previously. The target recruitment is betwen 12-18 and not every person will receive the same dose.
Volunteers enrolled onto the study will receive 2 vaccinations in total at the Liverpool Clinical Research Facility based within the Liverpool University Hospitals Royal Site. Blood and urine samples will be taken to confirm eligibility prior to receiving the study vaccine. On dosing days, volunteers will be required to remain on the unit for 1 hour post dose administration for observation and will then be discharged from the facility. There will be 9 outpatient appointments lasting a duration of 56 days.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0154
Date of REC Opinion
12 Jul 2022
REC opinion
Further Information Favourable Opinion