NCT00962624

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

August 19, 2009

Last Update Submit

September 17, 2018

Conditions

Meningococcal Meningitis, Serogroup AMeningococcal Meningitis, Serogroup BMeningococcal Meningitis, Serogroup CMeningococcal Meningitis, Serogroup YMeningococcal Meningitis, Serogroup W

Keywords

MeningococcalVaccineMeningitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay

    one month following the last vaccination

Interventions

meningococcal B vaccine & meningococcal ACYW conjugate vaccineDRUG

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.

Also known as: Meningococcal ACYW vaccine- MenVeo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester Medical Microbiology Partnership

Manchester, M13 9WZ, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 26025807BACKGROUND

  • Ramirez-Bencomo F, Thistlethwaite A, Viviani V, Bartolini E, Pizza M, Biolchi A, Muzzi A, Delany I, Awanye AM, Chang CM, Borrow R, Derrick JP. Identification of immunogenic outer membrane vesicle vaccine antigen components using a meningococcal protein microarray. Vaccine. 2025 Apr 19;53:126953. doi: 10.1016/j.vaccine.2025.126953. Epub 2025 Mar 4.

    PMID: 40043411DERIVED

MeSH Terms

Conditions

Meningitis, MeningococcalMeningitis

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Meningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMeningococcal InfectionsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • Ray Borrow, PhD

    Public Health England

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

August 19, 2009

First Posted

August 20, 2009

Study Start

July 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2012

Last Updated

September 19, 2018

Record last verified: 2018-09

Locations

GB(1)