NCT00197795

Brief Summary

To measure the serum bactericidal antibody levels and cell mediated immune responses before and six weeks after each dose of meningococcal outer membrane vesicle vaccine given at 0,6 and 12 weeks to healthy UK adults.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

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

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

September 12, 2005

Last Update Submit

August 23, 2018

Conditions

Neisseria Meningitidis

Interventions

Meningococcal outer membrane vesicle vaccine "MenBVac"BIOLOGICAL

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Informed written consent given for three immunizations with MenBVac and five blood tests
  • Between the ages of 18 and 55 years inclusive at recruitment

You may not qualify if:

  • Previous history of bacteriologically confirmed meningococcal disease
  • History of clinically significant allergic sensitivity to any vaccine received in the past
  • Immunodeficiency
  • Any other acute or chronic systemic illness or dependence or abuse of drugs or alcohol
  • Language difficulties sufficient to preclude adequate comprehension of the study information
  • Possibility of pregnancy
  • Receipt of any other vaccine in the previous 4 weeks
  • Receipt of any group B vaccine in the past
  • Current participation in any other clinical trial
  • Generalized acute systemic illness and/or temp \>38C on day of vaccination deferral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Findlow J, Taylor S, Aase A, Horton R, Heyderman R, Southern J, Andrews N, Barchha R, Harrison E, Lowe A, Boxer E, Heaton C, Balmer P, Kaczmarski E, Oster P, Gorringe A, Borrow R, Miller E. Comparison and correlation of neisseria meningitidis serogroup B immunologic assay results and human antibody responses following three doses of the Norwegian meningococcal outer membrane vesicle vaccine MenBvac. Infect Immun. 2006 Aug;74(8):4557-65. doi: 10.1128/IAI.00466-06.

    PMID: 16861642RESULT

Study Officials

  • Elizabeth Miller, MBBS FRCPath

    Public Health England

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant epidemiologist

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 24, 2018

Record last verified: 2018-08