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Regulation of Mucosal Immune Response to Systemic MenB Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774384
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : November 15, 2016
University of Bristol
Public Health England
Novartis Vaccines
North Bristol NHS Trust
Information provided by (Responsible Party):
University Hospitals Bristol and Weston NHS Foundation Trust

Brief Summary:
Meningitis or septicaemia (blood poisoning) caused by group B meningococcal infection (MenB) is an important cause of death and disability in the UK. Prevention through vaccination therefore remains a key public health priority. Research from national "meningitis" vaccine programmes against MenC, Hib and Streptococcus pneumoniae show us that their success is in part due to their ability to protect both the vaccinated and the unvaccinated, so-called herd immunity. This protection probably occurs by reducing carriage of these meningitis bacteria in the back of the throat (mucosal immunity). How this happens is poorly understood but our research shows that naturally acquired immunity (transient contact between the immune system and the meningococcus in the back of the throat without causing disease) may impact on this process. We believe that to develop a MenB vaccine that is able to cause mucosal immunity and prevent MenB carriage, it is important to understand the interaction between natural immunity and vaccination. In this study we propose to administer MenB vaccine to adults in order to investigate this process. Our findings will provide important insights into Men B immunity, inform the design of novel vaccine strategies and allow the rational testing of new vaccines as they become available.

Condition or disease Intervention/treatment Phase
Meningococcal Infections Biological: NZ MenB OMV vaccine (NZ98/254) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II, Open Label, Randomised, Single Centre Study To Evaluate The Importance Of Naturally Induced Immune Regulation On The Mucosal Immune Response To Meningococcal Serogroup B Outer Membrane Vesicle (Omv) Vaccine When Administered Intramuscularly To Adults & Adolescents
Study Start Date : September 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Immunisation with NZ MenB OMV vaccine (NZ98/254)
Biological: NZ MenB OMV vaccine (NZ98/254)
3 doses by intramuscular injection

No Intervention: 2
No vaccine

Primary Outcome Measures :
  1. T-cell proliferation following vaccination and its regulation. [ Time Frame: After 2 or 3 doses of vaccine ]

Secondary Outcome Measures :
  1. Serum bactericidal antibody and OMV ELISA antibody. [ Time Frame: After each does of vaccine ]
  2. Salivary antibody [ Time Frame: After each dose of vaccine ]
  3. B-cell memory [ Time Frame: After 2 or 3 doses of vaccine ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774384

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United Kingdom
Bristol, Avon, United Kingdom, BS2 8HU
North Bristol NHS Trust
Bristol, Avon, United Kingdom
Sponsors and Collaborators
University Hospitals Bristol and Weston NHS Foundation Trust
University of Bristol
Public Health England
Novartis Vaccines
North Bristol NHS Trust
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Responsible Party: University Hospitals Bristol and Weston NHS Foundation Trust Identifier: NCT00774384    
Other Study ID Numbers: SysVac01 - C60P2 PA/2008/2883
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Keywords provided by University Hospitals Bristol and Weston NHS Foundation Trust:
Neisseria meningitidis
T cells
T regulatory cells
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses