Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults (MenOccy)
Primary Purpose
Meningococcal Meningitis, Serogroup A, Meningococcal Meningitis, Serogroup B, Meningococcal Meningitis, Serogroup C
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
meningococcal B vaccine & meningococcal ACYW conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Meningitis, Serogroup A focused on measuring Meningococcal, Vaccine, Meningitis
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.
Sites / Locations
- Manchester Medical Microbiology Partnership
Outcomes
Primary Outcome Measures
Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay
Secondary Outcome Measures
Full Information
NCT ID
NCT00962624
First Posted
August 19, 2009
Last Updated
September 17, 2018
Sponsor
Prof. Elizabeth Miller
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00962624
Brief Title
Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults
Acronym
MenOccy
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Elizabeth Miller
Collaborators
Novartis Vaccines
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Meningitis, Serogroup A, Meningococcal Meningitis, Serogroup B, Meningococcal Meningitis, Serogroup C, Meningococcal Meningitis, Serogroup Y, Meningococcal Meningitis, Serogroup W
Keywords
Meningococcal, Vaccine, Meningitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
meningococcal B vaccine & meningococcal ACYW conjugate vaccine
Other Intervention Name(s)
Meningococcal ACYW vaccine- MenVeo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay
Time Frame
one month following the last vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray Borrow, PhD
Organizational Affiliation
Public Health England
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manchester Medical Microbiology Partnership
City
Manchester
ZIP/Postal Code
M13 9WZ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26025807
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.
Results Reference
background
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Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults
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