Regulation of mucosal immune response to systemic MenB vaccine ver. 15
Research type
Research Study
Full title
A PHASE II, OPEN LABEL, RANDOMISED, SINGLE CENTRE STUDY TO EVALUATE THE IMPORTANCE OF NATURALLY INDUCED IMMUNE REGULATION ON THE MUCOSAL IMMUNE RESPONSE TO MENINGOCOCCAL SEROGROUP B OUTER MEMBRANE VESICLE (OMV) VACCINE WHEN ADMINISTERED INTRAMUSCULARLY TO ADULTS & ADOLESCENTS (SysVac01 – C60P2)
IRAS ID
4155
Sponsor organisation
UHBristol NHS Foundation Trust
Eudract number
2008-001927-74
ISRCTN Number
na
Research summary
Meningitis or septicaemia(blood poisoning) caused by group B meningococcal infection (MenB) is animportant cause of death and disability in the UK. Prevention through vaccinationtherefore remains a key public health priority. Research from national??meningitis? vaccine programmes against MenC, Hib and Streptococcus pneumoniaeshow us that their success is in part due to their ability to protect both thevaccinated and the unvaccinated, so-called herd immunity. This protectionprobably occurs by reducing carriage of these meningitis bacteria in the backof the throat (mucosal immunity). How this happens is poorly understood but ourresearch shows that naturally acquired immunity (transient contact between theimmune system and the meningococcus in the back of the throat without causingdisease) may impact on this process. We believe that to develop a MenB vaccinethat is able to cause mucosal immunity and prevent MenB carriage, it isimportant to understand the interaction between natural immunity andvaccination. In this study we propose to administer MenB vaccine to adults in orderto investigate this process. Our findings will provide important insights intoMen B immunity, inform the design of novel vaccine strategies and allow therational testing of new vaccines as they become available.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
08/H0106/85
Date of REC Opinion
14 Nov 2008
REC opinion
Further Information Favourable Opinion