Clinical trial NCT00962624: Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults
Official title: A Phase 2, Open-label Study of the Safety, Tolerability and Immunogenicity of a Meningococcal B Vaccine When Administered at a 0, 2, 6 Months and of a Single Dose of Meningococcal ACWY Conjugate Vaccine in Healthy Adults Aged 18-65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Meningitis, Serogroup A
Meningococcal Meningitis, Serogroup B
Meningococcal Meningitis, Serogroup C
Meningococcal Meningitis, Serogroup Y
Meningococcal Meningitis, Serogroup W
Keywords: Meningococcal
Vaccine
Meningitis
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
Collaborators: name: Novartis Vaccines
First posted: 2009-08-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay
timeFrame: one month following the last vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Medical Microbiology Partnership
Study officials:
affiliation: Public Health England
name: Ray Borrow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Findlow J, Bai X, Findlow H, Newton E, Kaczmarski E, Miller E, Borrow R. Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers. Vaccine. 2015 Jun 26;33(29):3322-30. doi: 10.1016/j.vaccine.2015.05.027. Epub 2015 May 27.