BEAR Men B
Research type
Research Study
Full title
Babies born Early Antibody Response to Men B vaccination: BEAR Men B
IRAS ID
223266
Contact name
Subhir Bedi
Contact email
Sponsor organisation
Joint Research and Enterprise Services / St George's University of London
Eudract number
2017-001487-38
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
Meningitis (infection of the lining of the brain) and septicaemia (blood poisoning) have many causes; an important cause in the UK is a bacteria called Meningococcus. Vaccination protects against some forms of Meningococcus by encouraging the body to make antibody to the bacteria - a chemical which helps fight the bacteria if it is encountered.
In the UK babies are vaccinated according to the same schedule whether they are born early (preterm) or on time, but there are concerns that preterm babies may not respond as strongly to their vaccinations - this may result in less protection. In 2015 a new vaccine, the Men B vaccine, was introduced. There have been no studies done to determine whether this will work as well in preterm babies compared with term babies. This proposed project will compare responses made by babies who are vaccinated according to two different schedules. This could help us make decisions about what programme should be followed for preterm babies.
We will recruit 132 preterm babies. We will randomly (“toss of a coin”) assign these babies to one of the two study groups with one group receiving a Men B vaccine at 8 weeks and 16 weeks of age (the current UK schedule for Men B in term babies) and the other receiving an additional dose at 12 weeks. Both groups will receive an additional dose 'booster' dose at 12 months. We will obtain three blood tests over the study period to check the babies’ antibody levels and will ask caregivers to keep a record of any reactions that occur after their vaccinations.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0150
Date of REC Opinion
17 May 2017
REC opinion
Favourable Opinion