Regulation of Mucosal Immune Response to Systemic MenB Vaccine

Inclusion Criteria:

• written informed consent and agreement for samples to be sent overseas
• adults and adolescents 16−40 years scheduled to undergo routine tonsillectomy
• in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator
• availability for all the visits scheduled in the study

Exclusion Criteria:

• tonsillectomy for allergic conditions
• receipt of or intent to immunize with any vaccination (other than influenza vaccine or post−exposure tetanus vaccination) or investigational agents within 50 days prior to enrolment and throughout the study period
• previous receipt of any MenB vaccine
• chronic administration (defined as more than 14 days) of immunosuppressants or other immune−modifying drugs (Inhaled and topical steroids will not be allowed.)
• history of confirmed or suspected meningococcal infection or close contact with an individual with culture or PCR proven N. meningitidis serogroup B within the previous 60 days
• pregnancy (or plans to become pregnant during study)* or breast feeding
• not taking or unwilling to take sufficient measures to avoid pregnancy occurring for the duration of the study period**
• any chronic or progressive disease (eg neoplasm, cardiac, respiratory, liver, gastrointestinal, renal, neurological disease, autoimmune disease, blood dyscrasias or diathesis) or history of dependence/abuse of drugs or alcohol • any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
• administration of immunoglobulins and/or any blood products in the last year or planned administration during the study period
• history of any anaphylactic shock, asthma, urticaria or any other allergic reaction after previous vaccinations, or known hypersensitivity to any vaccine component
• fever (oral temperature equal to or greater than 38.5°C) within the past 24 hours or significant acute or chronic infection within the previous 7 days
• significant acute or chronic infections requiring systemic antibiotic treatment within the past 14 days
• not available for all the visits scheduled during the study period
• any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

• participation in another clinical trial within last 90 days or planned for during the study * A pregnancy test (urine) on the scheduled day of each vaccination will be required for any female wishing to participate in the study as well as giving basic menstrual cycle information to cover the period in which and individual may be pregnant but this would not be ascertained by the chemical test.

  • Females of childbearing age who have not used or do not plan to use acceptable birth control measures for the duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device are considered acceptable forms of birth control. If sexually active the subject should have been using one of the accepted birth control methods at least two months prior to study entry.