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    Summary
    EudraCT Number:2011-001943-60
    Sponsor's Protocol Code Number:SJF0001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-06
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-001943-60
    A.3Full title of the trial
    Cellular immunity in adult Hepatitis B-vaccinated serologic non-responders
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estimating the immune system in adults who do not develop sufficient levels of antibodies after vaccination against hepatitis B virus
    A.3.2Name or abbreviated title of the trial where available
    CMI HBV vacc
    A.4.1Sponsor's protocol code numberSJF0001
    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 SponsorLars Jørgen Østergaard
    B.1.3.4CountryDenmark
    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 supportDepartment of Infectious Diseases, Aarhus University Hospital Skejby
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLars Jørgen Østergaard
    B.5.2Functional name of contact pointLars Jørgen Østergaard
    B.5.3 Address:
    B.5.3.1Street AddressBrendstrupgaardsvej 100
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4589498300
    B.5.5Fax number+4589498310
    B.5.6E-maillaroes@rm.dk
    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 Twinrix Voksen
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameTwinrix Voksen
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameHEPATITIS A (INACTIVATED) AND HEPATITIS B (RDNA) VACCINE (ADSORBED)
    D.3.9.4EV Substance CodeSUB12017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) No
    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 individuals
    E.1.1.1Medical condition in easily understood language
    Healthy individuals
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10060023
    E.1.2Term Interferon gamma level
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10054130
    E.1.2Term Hepatitis B immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate induction of the cellular immunity against HBs antigen in adult serologic non-responders after standard HBV immunization measured by IFN gamma response.
    E.2.2Secondary objectives of the trial
    - To establish the prevalence of serologic non-response in healthy adult individuals after standard HBV immunization.
    - To evaluate predictors of serologic non-response in healthy adult individuals after standard HBV immunization.
    - To compare the immunologic profile in adult serologic non-responders vs adult serologic responders after standard HBV immunization
    - To evaluate the safety of a standard HBV immunization schedule
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Written informed consent and authority statement provided according
    to local regulatory and ethical practice using a participant information
    sheet and informed consent form approved by the responsible Ethics Committee.
    2) Male or female participants ≥ 18 years.
    E.4Principal exclusion criteria
    1) Allergy to formaldehyde (contained in Twinrix)
    2) Former HBV immunization
    3) Former HBV infection
    4) Known chronic HBV infection
    5) Participants unwilling to use reliable contraception for the duration of the trial (if female). Reliable methods of birth control include:
    pharmacologic contraceptives including oral, parenteral and transdermal
    delivery, surgical sterilization, vaginal ring, intrauterine device,
    abstinence and post-menopause (if female).
    6) Pregnancy or wish of pregnancy within six months after time of study inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    - HBsAg specific CD4+ cell IFN gamma response after standard HBV immunization
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Two months after completed HBV immunization
    E.5.2Secondary end point(s)
    - Quantitative measurement of anti-HBs antibodies after HBV immunization.
    - Predictors of serologic non-response: age, gender, BMI, smoking status
    - HBsAg specific cell mediated immune response: Secretion of IFN gamma, TNF alfa and IL-2 when stimulated with HBs antigen. Quantitative measures of cytokineproducing T-cells with subsequent flow cytometry.
    - HBsAg specific T-cell proliferation
    - T-cell phenotype analyses
    - HBsAg- specific B-cell analyses
    - Cytokine analyses on supernatant from HBsAg-stimulated PBMCs
    - Safety profile: Number and severity of AE, SAE and SUSARs
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Safety issues are evaluated after each vaccination
    - Demographic predictors of serologic non-response at time month 0
    - HBV serology and immune profile analyses at month 0 and 8
    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 Yes
    E.6.5Efficacy Yes
    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 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 No
    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 Yes
    E.8.2.3.1Comparator description
    no comparison of drugs, but comparison of serologic responders and serologic non-responders
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    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 state400
    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)
    None as study participants are healthy persons receiving a standard HBV immunization
    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 Decision2011-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-09
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