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

History of Changes

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:

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. Erratum in: Infect Immun. 2007 Aug;75(8):4187.

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 October 16, 2012

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