Immunogenicity and Reactogenicity of a Meningococcal B Outer Membrane Vesicle Vaccine Given in a 0,6,12 Month Schedule to Health UK Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Elizabeth Miller, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00197795
First received: September 12, 2005
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Neisseria Meningitidis
Biological: Meningococcal outer membrane vesicle vaccine "MenBVac"
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Further study details as provided by Health Protection Agency, United Kingdom:

Estimated Enrollment: 30
Study Start Date: January 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197795

Sponsors and Collaborators
Health Protection Agency, United Kingdom
Investigators
Principal Investigator: Elizabeth Miller, MBBS FRCPath Health Protection Agency, United Kingdom
  More Information

Publications:
Responsible Party: Dr. Elizabeth Miller, Consultant epidemiologist, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier: NCT00197795     History of Changes
Other Study ID Numbers: MNB1
Study First Received: September 12, 2005
Last Updated: March 27, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on April 17, 2014