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    Summary
    EudraCT Number:2014-000126-38
    Sponsor's Protocol Code Number:OVG2012/05
    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:2014-03-04
    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 number2014-000126-38
    A.3Full title of the trial
    Towards improved meningococcal vaccines: a randomised, descriptive, open label study exploring the relationship between gene expression signatures with reactogenicity and immunogenicity following vaccination with serogroup B meningococcal vaccine(4CMenB)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigating the immune response to 4CMenB in infants(EUCLIDS)
    A.3.2Name or abbreviated title of the trial where available
    Investigating the immune response to 4CMenB in infants(EUCLIDS)2+1
    A.4.1Sponsor's protocol code numberOVG2012/05
    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 of Oxford
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointOxford Vaccine Group
    B.5.3 Address:
    B.5.3.1Street AddressCCVTM, Churchill Hospital, Old Road
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 7LE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865857420
    B.5.5Fax number01865857420
    B.5.6E-mailandrew.pollard@paediatrics.ox.ac.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 Yes
    D.2.1.1.1Trade name Bexsero
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics S.r.l.,
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameBexsero
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant Neisseria meningitidis group B NHBA fusion protein
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant Neisseria meningitidis group B NadA protein
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant Neisseria meningitidis group B fHbp fusion protein
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOuter membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This study aims to investigate gene expression following vaccination with 4CMenB and relate this to vaccine reactions and to immune response
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    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
    To describe the kinetics of global gene expression (i.e. the pattern of which genes are switched on/off) in whole blood, following vaccination with 4CMenB vaccine in healthy infants.
    E.2.2Secondary objectives of the trial
    1. To compare gene expression following vaccination with 4CmenB to immunogenicity as determined by serum bactericidal antibody titres (a measure of how well the body has made antibodies capable of killing MenB)against reference strains of serogroup B N. meningitidis.

    2. To investigate changes in the epigenome within individuals following vaccination with 4CMenB.

    3. To relate changes in gene expression to changes in B cell populations.

    4. To relate changes in gene expression to changes in plasma proteins.

    5. To describe any changes in oro-pharyngeal Neiserrial flora occurring after vaccination,as determined by analysis of the pharyngeal microbiome.

    Exploratory objectives

    1. To explore relationships between reactogenicity, gene expression and immunogenicity (are gene expression patterns different between good / poor responders, are fever and immunogenicity related)

    2. To explore genetic determinants of response to vaccination with 4CMenB

    3. To explore the relati
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Healthy infants of two Caucasian parents (self-defined by parent) born between 37 and 42 weeks of gestation aged 8-12 weeks at time of first visit
    •Parent or legal guardian willing and able to comply with the requirements of the protocol and have internet access for the duration of the study.
    •Parent/legal guardian who have given informed consent for their child’s participation in the study
    E.4Principal exclusion criteria
    •Non-Caucasian infants
    •Children of parents who are on the delegation log for this study
    •Parent/ legal guardian under the age of 18
    •History of invasive meningococcal B disease
    •Previous vaccination with meningococcal serogroup B vaccine
    •History of being a household contact with a case of confirmed bacterial meningitis
    •Prior administration of any vaccine or planned administration of any vaccine not specified in the study protocol, with the exception of Hepatitis B vaccine and Influenza vaccines (which can be given 14 days before or after study vaccines), or BCG (which can be administered 28 days before or after study vaccines)
    •Prior or planned receipt of any other investigational vaccine or drug
    •Confirmed or suspected immunodeficiency
    •A family history of congenital or hereditary immunodeficiency, or maternal HIV
    •Receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone >0.5ml/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed.
    •History of allergy to any component of the vaccine
    •Major congenital defects or serious chronic illness
    •History of any neurologic disorders or seizures
    •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
    •Any other condition which, in the opinion of the investigator, may interfere with the ability to fulfil study requirements (this may include plans to move house and language comprehension).
    •No internet access for the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Analysis of differentially expressed genes in whole blood at 4hr, 24hr, 3d and 7d timepoints following vaccination with 4CMenB and routine immunisations, or routine immunisations alone.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis of differentially expressed genes in whole blood at 4hr, 24hr, 3d and 7d time points following the 2nd and 3rd doses of 4CMenB vaccine when given at 2, 4 and 12 months of age together with routine immunisations, or following routine immunisations alone given at equivalent time points
    E.5.2Secondary end point(s)
    • To compare gene expression following vaccination with 4CMenB to immunogenicity as determined by serum bactericidal antibody titres against reference strains of serogroup B N. meningitidis
    • To investigate changes in the epigenome within individuals following vaccination with 4CMenB
    • To relate changes in gene expression to changes in B cell populations
    • To relate changes in gene expression to changes in plasma proteins
    • To describe any changes in the oro-pharyngeal flora occurring after vaccination, as determined by analysis of the overall oro- pharyngeal Neisseria microbiome
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Measurement of SBA titre against three Neisseria meningitidis strains: NZ98/254, 5/99 and 44/76-SL (as well as additional strains as indicated) at 5, and 13 months of age in children receiving 4CMenB at 2, 4 and 12 months of age
    • Measurement of epigenome modifications, potentially including changes in methylation and histone modification DNA
    • Quantification of 4CMenB antigen-specific antibody secreting cells by ELISPOT at day 7 and day 28 after the 2nd and 3rd doses of 4CMenB vaccine given at 2, 4 and 12 months of age
    • Analysis of gene expression profiles in PBMCs +/- lymphocyte subsets
    • Exploratory measurement of plasma proteins.
    • Investigation of the oro-pharyngeal Neisseria microbiome, at 5 and 13 months in all study children.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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 Yes
    E.8.2.3.1Comparator description
    Usual paediatric immunisations according to the UK national immunisation schedule
    E.8.2.4Number of treatment arms in the trial8
    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 concerned6
    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
    The end of study will be when all biological samples have been processed
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 160
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state160
    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)
    Not applicable
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-27
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