Meningococcal B Booster Vaccine in Young People
Research type
Research Study
Full title
Preventing meningitis in young people after infant immunisation: effect of a single meningococcal 4CMenB vaccine booster over 10 years of age
IRAS ID
231165
Contact name
Andrew Pollard
Contact email
Sponsor organisation
University of Oxford
Eudract number
2017-004732-11
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
In 2015 4CMenB Vaccine (Bexsero®) (a vaccine against the bacteria meningococcus B) was added to the UK routine immunisation schedule for infants. The aim of this study is to determine if it is sufficient to give a single booster dose of 4CMenB to 11 year olds that have received a full course of the vaccine in their infancy, in order to ensure that they are protected from meningococcal B disease in adolescence. The reason to consider this is because meningococcus B causes disease in 2 main waves, the first in infancy and the second in adolescence.
The first children to receive 4CMenB in the UK were a group recruited to studies done at the Oxford Vaccine Group around 11 years ago. We are planning to approach these children to determine if they still have immunity against meningococcus B so many years after receiving the vaccine, and whether their immunity can be sufficiently topped up with just a single dose of the vaccine as a booster. We will be comparing this with children who have never had 4CMenB (the control groups), and we will be giving these children either one or two doses of 4CMenB during the study. This allows us to compare the range of immune responses in several different groups of children to different schedules of 4CMenB. The study will ultimately inform decisions about whether or not to include an adolescent booster meningococcal B vaccine into the UK routine immunisation schedule.
Children who have never received a meningococcal B vaccine before usually require 2 doses to become immune to the disease. Therefore children from the control group who only receive one dose of 4CMenB will receive a second dose at the end of the study, as per the vaccine license.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0466
Date of REC Opinion
19 Jan 2018
REC opinion
Further Information Favourable Opinion