Investigating the immune response to 4CMenB in infants(EUCLIDS)2+1
Research type
Research Study
Full title
Towards improved meningococcal vaccines: a randomised, descriptive, open label study exploring the relationship between gene expression signatures with reactogenicity and immunogenicity following vaccination with serogroup B meningococcal vaccine(4CMenB)
IRAS ID
147462
Contact name
Andrew Pollard
Contact email
Sponsor organisation
Clinical Trails and Research Governance
Eudract number
2014-000126-38
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Until recently,there was no broadly protective vaccine against group B meningococcus (MenB)which causes over 90% of meningococcal disease in the UK(approximately 600 cases per year). A new vaccine,4CMenB (also called Bexsero),was recently approved for the prevention of MenB disease from 2 months of age and older. This vaccine is not yet routinely available for use in the UK. Unfortunately,the 4CMenB vaccine is associated with significant rates of reactions such as fever, when compared to routine infant vaccines which and this may make it an unacceptable vaccine to parents.In this study we will seek to understand the relationship between early gene expression profiles(i.e. which genes are switched on/off),vaccine reactions and measure of effectiveness,in children who receive routine immunisations with or without 4CMenB. This will provide information about the mechanisms by which the 4CMenB vaccine works and may also identify which genes are responsible for the reactions seen with this vaccine.The information generated will be useful in future vaccine design and evaluation.In this study, participants will receive their routine vaccines in accordance with the UK immunisation schedule. In addition, they will receive the 4CMenB vaccine at specified time points.There will be two main groups;a test and control group. Blood will be taken after vaccination,at “early“ time points (4hrs, 24hrs, 3d or 7d)and a late time point (28d) after the second and thrid 4CMenB vaccine doses(or the equivalent time point in the control group).We will also look at the effect that immunisation with 4CMenB has on the presence of MenB and related bacteria that are normally carried in the back of the throat.This will be done by obtaining throat swabs at specified vaccine visits. Local and/or systemic reactions will also be collected to allow a three way comparison of immunogenicity,gene expression profile and reactogenicity (e.g. presence of fever, local reaction).
REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/0077
Date of REC Opinion
25 Feb 2014
REC opinion
Further Information Favourable Opinion