Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-002720-91
    Sponsor's Protocol Code Number:HBnr02
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-11-28
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-002720-91
    A.3Full title of the trial
    Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non-responders.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 clinical study into the immune responde and adverse effects of a Hepatitis B vaccine in subjects that do not respond (non-responders) to the Hepatitis B vaccine.
    A.3.2Name or abbreviated title of the trial where available
    Phase 2 HBAI20 Hepatitis B vaccine in non-responders
    A.4.1Sponsor's protocol code numberHBnr02
    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 SponsorCyTuVax BV
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCyTuVax BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University Medical Center
    B.5.2Functional name of contact pointDepartment of Medical Microbiology
    B.5.3 Address:
    B.5.3.1Street AddressPeter Debyeplain 25
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 HX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031433876644
    B.5.6E-mailsecretariaatmmb@mumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 HBVAXPRO 10 micrograms, suspension for injection in pre-filled syringe Hepatitis B vaccine (rDNA)
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR MSD SNC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameHBVaxPRO 10 micrograms
    D.3.4Pharmaceutical form Solution 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.3.8INN - Proposed INNHBVaxPro
    D.3.9.3Other descriptive nameHEPATITIS B VACCINE (RDNA)
    D.3.9.4EV Substance CodeSUB12020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 nameHBAI20
    D.3.2Product code HBAI20
    D.3.4Pharmaceutical form Solution 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.3.8INN - Proposed INNHBVaxPro
    D.3.9.3Other descriptive nameHEPATITIS B VACCINE (RDNA)
    D.3.9.4EV Substance CodeSUB12020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInterleukin-2
    D.3.9.1CAS number 8000048-25-1
    D.3.9.3Other descriptive nameINTERLEUKIN-2
    D.3.9.4EV Substance CodeSUB14225MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    In a minority of the population (5-10%) standard vaccines against Hepatitis-B do not induce protective immunity, even after prolonged and repeated vaccination courses. Non- responsiveness to hepatitis-B vaccination poses a severe problem for people with high risk of infection (e.g. medical and laboratory staff, surgeons). Several approaches have been proposed to overcome non- responsiveness, however these work only to a minimal extent leaving too many people unprotected.
    E.1.1.1Medical condition in easily understood language
    There are vaccines against hepatitis-B virus (HBV) that work well in most people. In a minority of the population 'non-responders' (5-10%), these vaccines fail to produce protection against HBV.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    The primary study parameter is the determination the immunogenicity of the HBAI vaccine and how it compares with the standard HBVaxPro-10µg. The immunogenicity will be measured as the antibody titer specific for Hepatitis B which will be collected by the COBAS® system (Roche). The immunogenicity of the different vaccines will be assessed primarily as the percentage of individuals that become seroprotected with an anti HBsAg antibody titer equal or higher than 10mIU/ml. Other measurements of immunogenicity will the the Geometric Mean Titre and frozen PBMC will be used to investigate cellular immunogenicity of the different vaccines. In particular: epitope specificity, differentiation, maturation, and functionality of CD4+ T cells specific for HBsAg.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety and tolerability of the CyTuVax Hepatitis B vaccine in non-responders: assessment of the local and systemic adverse reactions. The time frame for the determination of the vaccine safety is within the first 30 days after first, second, and 45 days after the third vaccination. The whole duration of the study protocol, which include the 3 vaccinations with the IMP and the 6 weeks after, are consider the safety assessment period. Adverse effects will be recorded as described on section 8.1.1 of the present document.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the clinical investigator
    Age 18 to 59 years, inclusive at the time of enrollment
    Willing and able to adhere to the study regimen
    Having a signed informed consent form
    Documented non-responders: Subjects with documented one or more cycles of Hepatitis B vaccination (total of 3 or more vaccinations) and titer analysis that show that they have not developed the Hepatitis B antibody titer recommended after standard vaccination: anti-HBsAg antibody titer superior to 10mIU/ml
    E.4Principal exclusion criteria
    Any infectious disease at the time of screening and/or enrollment
    Positive HIV, Hepatitis B virus or Hepatitis C virus serology
    Known or suspected immune deficiency
    Known or suspected disease that influences the immune system including chronic allergies that require frequent anti-allergy medication, cancer and transplantation recipients
    Known or suspected allergy to any of the vaccine components: see IB, IMPD
    Dialysis patient
    History of unusual or severe reactions to any previous vaccination
    History of any neurologic disorder, including epilepsy and autism
    Use of medication that influences the immune system (immune suppressive treatment or daily use of corticosteroids)
    Any vaccination within 3 months before screening
    Blood donation within 1 month before screening
    Administration of plasma (incl. immunoglobulins) or blood products within 12 months before screening
    Participation in another clinical trial within 3 months before screening
    Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
    Bleeding disorders, or use of medication for bleeding disorders, and use of anti-coagulants
    Female subjects planning to become pregnant or breastfeeding babies until visit 4
    Females: positive urine pregnancy test at screening date
    Excessive alcohol or controlled drug use - More than 2 alcohol measures per day (one alcohol measure is a beer (250ml) or one glass of wine (125ml) or one strong measure (35ml) or one port/sherry (75ml)). Regular use of controlled drugs
    Any Hepatitis B vaccination in the last 6 months
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is the immunogenicity of the adjuvanted vaccine. The immunogenicity of the vaccine is assessed as the percentage of subjects that have an anti HBsAg antibody titer higher or equal to 10mIU/ml 6 weeks after the 3rd vaccination. The antibody titers specific for Hepatitis B will be measured using an immunochemistry COBAS assay.
    E.5.1.1Timepoint(s) of evaluation of this end point
    102 days after the beginning of the study. 42 days after the last vaccination
    E.5.2Secondary end point(s)
    The secondary endpoints for safety are the number and intensity of local and systemic adverse reactions and the determination of the dose.
    To determine the safety of the adjuvanted vaccine, subjects will be observed during the first 30 minutes after vaccination in order to record the occurrence of acute reactions. A diary will be given to each subject for reporting of adverse events on the day of vaccination and during the next 4 days after the day of vaccination for a total of 5 days.
    E.5.2.1Timepoint(s) of evaluation of this end point
    102 days after the beginning of the study. 42 days after the last vaccination
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Last visit of the last subject undergoing the clinical trial.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 140
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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
    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 Decision2017-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-03
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 06 00:14:32 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA