Meningococcal B Vaccination in University Students

NCT00443157 | Completed Phase 2

• 1 other identifier: MNB3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the third in a series using the MenB vaccine from the National Institute of Public Health in Norway (NIPH). The vaccine was first made in response to a high incidence of disease using the 44/76 strain which was resopnsible for most of the disease there. The VEC did the first study, MNB1, using this vaccine. Since then the NIPH has formed a commercial partnership with Chiron Vaccines and has reformulated the vaccine using the NZ98/254 MenB strain for use in New Zealand. The vaccine was first produced at NIPH facilties and it was this vaccine that was used in our second study, MNB2. The current study, MNB3, will use the NZ98/254 MenB vaccine but from Chiron facilities where production has been scaled up in order to provide enough doses for the national immunisation campaign that is ongoing in New Zealand.

Conditions

Neisseria Meningitidis Serogroup B

Keywords

meningococcal B vaccine

Outcome Measures

Primary Outcomes (1)

• serum bactericidal antibody

Secondary Outcomes (3)

• Serum antibody ELISA

• Immunoblotting

• Opsonophagocytosis assay

Interventions

Meningococcal B Vaccine NZ BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed written consent given for four immunisations (group 2 will receive 3 doses only) with MeNZB TM vaccine, as well as for eight blood draws to be taken as described in the patient information leaflet in appendix 2

You may not qualify if:

• On enrolment:
• Previous history of bacteriologically confirmed disease caused by N. meningitidis
• Prior receipt of any group B meningococcal vaccine
• have had household contact with and/or intimate exposure to an individual with culture or PCR proven N. meningitidis serogroup B within the previous 60 days
• have either received, or for whom there is intent to immunize with, any vaccines or investigational agents within 50 days prior to enrolment, through to 50 days following the last study vaccine administration, with the exception of influenza vaccines or post-exposure tetanus vaccination
• have a history of any anaphylactic shock, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
• have experienced significant acute or chronic infections requiring systemic antibiotic treatment within the past 14 days
• have any present or suspected serious acute or chronic disease such as: cardiac or autoimmune disease, insulin dependent diabetes or progressive neurological disease or severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease; leukaemia, lymphomas, neoplasm;
• have a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy, including systemic steroids, or ACTH or inhaled steroids in dosages which are associated with hypothalamic-pituitary-adrenal axis suppression;
• have received blood, blood products or a parenteral immunoglobulin preparation in the past 12 weeks;
• have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
• have a history of seizure disorder;
• have an inherited genetic anomaly (known cytogenic disorders) e.g., Down's syndrome;
• Language difficulty sufficient to preclude adequate comprehension of the information sheet, consent form or study nurse's explanation of the study;
• Current regimen of chronic prescription medications other than oral contraceptives, or current regular use of any over-the-counter concomitant medications including antipyretics and non-steroidal anti-inflammatory agents;

Sponsors & Collaborators

• Public Health England: lead

Study Sites (1)

University of Sheffield Medical School

Sheffield, United Kingdom

Location

Study Officials

• Elizabeth Miller, MBBS FRCPath

  Public Health England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: February 1, 2006
• Study Completion: March 1, 2007
• Last Updated: August 29, 2018

Record last verified: 2007-09

Locations

GB (1)