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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neisseria Meningitidis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Meningococcal outer membrane vesicle vaccine "MenBVac"

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes