FlaviPrime - Cross priming potential of IMOJEV JE Vaccine
Research type
Research Study
Full title
Flavivirus cross-priming potential of live attenuated Japanese encephalitis (JE) vaccine IMOJEV in flavivirus naïve and flavivirus experienced participants (FlaviPrime).
IRAS ID
264195
Contact name
Lance Turtle
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Summary of Research
This will be an open label, two arm, human experimental medicine study in healthy flavivirus naïve (group 1) and flavivirus exposed (group 2) volunteers. Each arm will receive a single dose of JE vaccine IMOJEV® and follow an identical schedule.The participants’ involvement will last 8 weeks from the point of vaccination at which point participants will be followed up in the observational Flavimmune study, aiming for 5 years of follow up.
Group 1: 2 healthy adults who have never travelled to a flavivirus endemic area and are negative in screening tests for flavivirus immunity.
Group 2: 4 healthy adults who have had JE vaccine and/or are previously flavivirus exposed, either through receiving yellow fever vaccine up to 5 years before the study, or from being diagnosed with a flavivirus illness (e.g. dengue or Zika).
Potential FlaviPrime participants will be identified through the Flavimmune study. Following this, they will be asked to consent to enrolment for FlaviPrime.
A total of 6 participants will be studied between the two groups (Group 1 = 2 and Group 2 = 4. Groups can comprise male and/or female participants aged from 18 to 70 years at the time of consent.
Each group will receive a single dose of live JE vaccine IMOJEV® and follow an identical schedule. All doses will be administered at the RLBUHT CRU facility in accordance with a bespoke vaccination administration working instruction. Participants will be in the study for a total of 8 weeks and will be expected to attend study visits to assess Adverse Events (AEs) and provide a blood sample at weeks 1, 2, 4, and 8.
Summary of Results
Apologies but the last submission said there were no adverse events. This is not correct – there were no severe adverse events.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
19/NW/0330
Date of REC Opinion
25 Jul 2019
REC opinion
Further Information Favourable Opinion