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

Neisseria Meningitidis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197795
• Other study ID #: MNB1
• Status: Completed
• Phase: Phase 2
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: August 2018
• Source: Public Health England
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Neisseria Meningitidis

Intervention

Biological:
• Meningococcal outer membrane vesicle vaccine "MenBVac"

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Public Health England

References & 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 — View Citation