Regulation of Mucosal Immune Response to Systemic MenB Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by United Bristol Healthcare NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Bristol
Health Protection Agency, United Kingdom
Novartis Vaccines
North Bristol NHS Trust
Information provided by (Responsible Party):
United Bristol Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT00774384
First received: October 16, 2008
Last updated: February 3, 2012
Last verified: January 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by United Bristol Healthcare NHS Trust:

Primary Outcome Measures:
  • T−cell proliferation following vaccination and its regulation. [ Time Frame: After 2 or 3 doses of vaccine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum bactericidal antibody and OMV ELISA antibody. [ Time Frame: After each does of vaccine ] [ Designated as safety issue: No ]
  • Salivary antibody [ Time Frame: After each dose of vaccine ] [ Designated as safety issue: No ]
  • B−cell memory [ Time Frame: After 2 or 3 doses of vaccine ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774384

Contacts
Contact: Adam Finn, MA PhD FRCP FRCPCH +44 117 342 0172 Adam.Finn@bristol.ac.uk

Locations
United Kingdom
UBHT Recruiting
Bristol, Avon, United Kingdom, BS2 8HU
Principal Investigator: Adam Finn, MA PhD FRCP FRCPCH         
North Bristol NHS Trust Recruiting
Bristol, Avon, United Kingdom
Sponsors and Collaborators
United Bristol Healthcare NHS Trust
University of Bristol
Health Protection Agency, United Kingdom
Novartis Vaccines
North Bristol NHS Trust
  More Information

No publications provided

Responsible Party: United Bristol Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT00774384     History of Changes
Other Study ID Numbers: SysVac01 - C60P2
Study First Received: October 16, 2008
Last Updated: February 3, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by United Bristol Healthcare NHS Trust:
Neisseria meningitidis
Mucosal
Vaccination
Immunity
T cells
T regulatory cells

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 28, 2014