Phase II MenB and MenACWY adult study
Research type
Research Study
Full title
A phase 2, open-label study of the safety, tolerability and immunogenicity of a Novartis meningococcal B vaccine when administered at a 0, 2, 6 month schedule and of a single dose of Novartis meningococcal ACWY conjugate vaccine in healthy adults aged 18-65 years.
IRAS ID
11889
Contact name
Ray Borrow
Contact email
Sponsor organisation
Health Protection Agency
Eudract number
2008-007182-23
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
Research summary
Meningococci are bacteria which can cause life-threatening meningitis. Laboratory staff working at the Manchester Medical Microbiology Partnership (MMMP) work with meningococci on a daily basis. Stringent safety measures are in place to ensure the safety of staff. However, a minor possibility of potential exposure due to the bacteria remains.
As for other vaccine preventable diseases where occupational exposure is possible (e.g. Hepatitis B), vaccination is recommended. However, for the five disease causing meningococcal groups, there is no licensed vaccine for group B and a poorly immunogenic vaccine for A,C,Y,W. The ACYW vaccine is currently given to new starters but only provides short lasting protection. Furthermore, re-vaccination with the same vaccine can result in a poorly understood phenomenon called hyper-responsiveness where antibody levels decrease as the immune system becomes tolerised. This could potentially make staff at greater risk to disease.
Recently, Novartis Vaccines have developed a pioneering vaccine against group B and a new separate ACYW vaccine which have proved very promising in phase I and II studies.
The development of these vaccines gives the opportunity to complete a study of their safety and immunogenicity in laboratory staff with potential occupational exposure to meningococci. This study will be sponsored and completed at the MMMP and will only recruit laboratory staff between 18-65 which are at potential occupational exposure to meningococci. Subjects will receive one dose of the group B vaccine and three doses of the group A,C,W,Y vaccine. Five blood samples will be taken to measure the immune response (antibody production). There is no requirement for staff to participate and this will be continually emphasised.
This study has the potential of increasing protection of staff against meningococcal disease and may also be used to inform future occupational health vaccination policy. Results will be published and add to data on both of these vaccines.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
09/H0803/118
Date of REC Opinion
11 Jan 2010
REC opinion
Further Information Favourable Opinion