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

Public Health England

Status and phase

Completed

Phase 2

Conditions

Neisseria Meningitidis

Treatments

Biological: Meningococcal outer membrane vesicle vaccine "MenBVac"

Study type

Interventional

Funder types

Other

Identifiers

NCT00197795

MNB1

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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