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    Summary
    EudraCT Number:2008-001927-74
    Sponsor's Protocol Code Number:SysVac01-C60P2 (PA/2008/2883)
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2008-001927-74
    A.3Full title of the trial
    A PHASE II, OPEN LABEL, RANDOMISED, TWO 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 ADMINISTRATED INTRAMUSCOLARLY TO ADULTS & ADOLESCENTS (SysVac01-C60P2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This project takes tests a vaccine against Meningitis provided by Novartis Vaccines and produced using the “New Zealand strain” of meningococcal serogroup B to examine how the mucosal immune cells contained within the tonsils of adult and adolescent healthy participants will respond to vaccination.
    A.3.2Name or abbreviated title of the trial where available
    Regulation of mucosal immune response to systemic MenB vaccine
    A.4.1Sponsor's protocol code numberSysVac01-C60P2 (PA/2008/2883)
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospitals Bristol NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNot applicable
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Bristol NHS Foundation Trust
    B.5.2Functional name of contact pointMary Perkins
    B.5.3 Address:
    B.5.3.1Street AddressUHB Education Centre, Level 3, Upper Moudlin Street
    B.5.3.2Town/ cityBristol
    B.5.3.3Post codeBS2 8HU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01173420233N/A
    B.5.5Fax number01173420239N/A
    B.5.6E-mailreoffice@ubht.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namemeningococcal serogroup B outer membrane vesicl
    D.3.2Product code MeNZB
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    "Healthy volunteers"
    In this project we will establish whether naturally induced mucosal CD25+ T regulatory activity in adults and adolescents modulates the mucosal immune response to systemic MenB OMV vaccination; and investigate the impact of this regulation on mucosal B cell memory.
    E.1.1.1Medical condition in easily understood language
    Subjects are evaluated for meningococcal bactericidal activity,antibody levels,anti-meningococcal responses from their saliva,Tonsillar mononuclear cells after routine tonsillectomy operation
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We ask whether specialised immune cells called CD25+ regulatory T cells (Treg)operating in the back of the throat explain the failure of immunisation to boost mucosal T−cell immunity in teenagers and young adults.
    E.2.2Secondary objectives of the trial
    1) Determine whether it is immunity to particular MenB molecules (antigen specificity of the mucosal CD25+ Treg population) that regulates MenB immunity. 2) Investigate the impact of this regulation on other mucosal immune cells (B cell memory).
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    N/A
    E.3Principal 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 .At least eight weeks prior to the expected date of tonsillectomy.
    E.4Principal 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 (axillary/tympani temperature >= 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.
    E.5 End points
    E.5.1Primary end point(s)
    1. T cell phenotype and function: Mucosal and systemic T-cells (CD45RO+ or CD25+ depleted) will be assessed for proliferation and phenotype. 2. Mucosal B cell antibody production: The number of tonsil cells producing vaccine protein antigen specific IgG, IgA and IgM will be measured both immediately following cell isolation and also following antigenic and mitogenic stimulation in culture. 3. Salivary antibody: anti-meningococcal antibodies (igG and IgA) will be measured by ELISA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples will be assessed right before the scheduled tonsillectomy and 12 weeks before it, saliva samples will be assessed right before the scheduled tonsillectomy, 12 weeks, and 6 weeks before it.
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Study mucosal immunity to Meningococcal protein antigens
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    N/A
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-18
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