Meningococcal Meningitis, Serogroup A, Meningococcal Meningitis, Serogroup B, Meningococcal Meningitis, Serogroup C, Meningococcal Meningitis, Serogroup W, Meningococcal Meningitis, Serogroup Y
Conditions
Keywords
Meningococcal, Vaccine, Meningitis
Brief summary
The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.
Detailed description
Laboratory staff at the Manchester Medical Microbiology Partnership may be at potential occupational exposure to meningococci. No licensed vaccine is available against serogroup B meningococci and the available plain polysaccharide serogroup ACYW vaccine is poorly immunogenic. Novartis Vaccines have developed an investigational serogroup B vaccine and a conjugated ACYW vaccine. This study will investigate these vaccines ability to induce a protective response in laboratory staff from the Manchester Medical Microbiology Partnership. Three doses of the meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose will be administered at 0 months. Blood samples will be taken before and after each vaccination and functional antibodies determined.
Interventions
DRUGmeningococcal B vaccine & meningococcal ACYW conjugate vaccine
Meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose of meningococcal ACYW vaccine will be administered at 0 months, concomitantly with the first dose of the meningococcal B vaccine.
Sponsors
Novartis Vaccines
Prof. Elizabeth Miller
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18-65 years of age * Who have given written informed consent after the nature of the study has been explained. * Who work within the Manchester Medical Microbiology Partnership and may be at potential occupational exposure to meningococci.
Exclusion criteria
* The possibility of pregnancy * A serious chronic disease including progressive neurological disease or seizure disorder. * Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. * Have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component. * Have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay | one month following the last vaccination |
Countries
United Kingdom
Outcome results
None listed