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    Summary
    EudraCT Number:2012-003217-33
    Sponsor's Protocol Code Number:ViDImmun
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-003217-33
    A.3Full title of the trial
    Immunological response of a single dose of 100,000 I.U. of cholecalciferol (vitamin D3)
    Immunologische Wirkungen einer Einmalgabe von 100.000 I.E. Cholecalciferol (Vitamin D3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunological response of vitamin D
    Immunologische Wirkung von Vitamin D
    A.4.1Sponsor's protocol code numberViDImmun
    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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportHEYL Chem.-pharm. Fabrik GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointAllergy-Center-Charité, CCM
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930450518092
    B.5.5Fax number+4930450518931
    B.5.6E-mailsekretariat-worm@charite.de
    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 D3-Vicotrat
    D.2.1.1.2Name of the Marketing Authorisation holderHeyl
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOLECALCIFEROL
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor codeVitamin D3
    D.3.9.3Other descriptive nameD3-Vicotrat
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboOther use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    relative vitamin D3 deficiency
    relativer Vitamin D3 Mangel
    E.1.1.1Medical condition in easily understood language
    relative vitamin D3 deficiency
    relativer Vitamin D3 Mangel
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10046242
    E.1.2Term Unspecified vitamin D deficiency
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is to assess the impact of vitamin D3 on immune cells (frequency of CD38+ B-cells) in subjects with relative vitamin D3 deficiency after one injection of 100,000 I.U. either intramuscular or subcutaneous.
    Hauptziel dieser Untersuchung ist die Vitamin D3-abhängige Modulation von Immunzellen (Frequenz von CD38+ B-Lymphozyten) nach einmaliger intramuskulären oder subkutanen Injektion von 100.000 I.E. bei Probanden mit relativen Vitamin D3 Mangel.
    E.2.2Secondary objectives of the trial
    Frequence of vitamin D3-responsive T-cells and myeloid antigen presenting cells carrying vitamin D3-sensitive surface markers.
    Immunological parameters (T-cell phenotype and cytokine profile, B-cell-phenotype, activation of monocytes, specific immunoglobulins)
    Pharmacokinetic
    Safety
    Tolerability
    Frequenz von T-Zell und myeloiden antigenpräsentierenden Zellen (APZs), die klassische Vitamin D3-induzierte Oberflächenmarker aufweisen.
    Immunologische Parameter (T-Zell-Phänotyp und Zytokinprofil, B-Zell-Phänotyp, Monozytenaktivierung, spezifische Immunglobuline)
    Pharmakokinetik
    Sicherheit
    Verträglichkeit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - written informed consent
    - men and women aged between 18 - 60 years
    - 25-hydroxyvitamin D3 serum concentration </= 50 nmol/l
    - schriftliche Einwilligungserklärung
    - Männer und Frauen im Alter von 18 - 60 Jahren
    - 25-Hydroxyvitamin D3 Konzentration im Serum </= 50 nmol/l
    E.4Principal exclusion criteria
    Main exclusion criteria
    - 25-hydroxyvitamin D3 serum concentration >50 nmol/l
    - BMI <18.5 or >30 kg/m²
    - regular or planned UV exposure
    - hypersensitivity against ingredients of the study drug
    - anamnesis: any disease which is a contraindication for the IMP
    - use of vitamin A or other vitamin D derivates
    - treatment with any medication which might interfere with the study drug or is an contra indication
    - pregnancy and lactation
    - 25-Hydroxyvitamin D3 Konzentration im Serum >50 nmol/l
    - BMI <18,5 oder >30 kg/m²
    - regelmäßige oder geplante UV-Exposition
    - Überempfindlichkeit gegen Bestandteile der Studienmedikation
    - anamnestische Erkrankungen die eine Kontraindikation für das IMP darstellen
    - Behandlung mit Vitamin A-Derivaten oder anderen Vitamin D-haltigen Präparaten
    - Behandlung mit Medikamenten, die die Behandlung beeinträtigen könnten oder Kontraindikationen darstellen
    - Schwangerschaft und Stillzeit
    E.5 End points
    E.5.1Primary end point(s)
    Frequency of CD38+ B-cells as pre-post comparison after vitamin D3 injection (i.m. or s.c.).
    Frequenz von CD38+ B-Lymphozyten im vorher-nachher Vergleich bei Vitamin D3-Gabe (i.m. oder s.c.)
    E.5.1.1Timepoint(s) of evaluation of this end point
    before as well as 7, 28 and 84 days after study drug application
    vor sowie 7, 28 und 84 Tage nach Applikation der Studienmedikation
    E.5.2Secondary end point(s)
    Frequency of vitamin D3-responsive T-cells and myeloid antigen presenting cells carrying vitamin D3-sensitive surface markers.
    Immunological parameters (T-cell cytokine profile, activation of monocytes, specific immunoglobulins)
    Pharmacokinetic
    Safety
    Tolerability
    Immunologische Parameter (T-Zell-Zytokinprofil, Monozytenaktivierung, spezifische Immunglobuline)
    Pharmakokinetik
    Sicherheit
    Verträglichkeit
    E.5.2.1Timepoint(s) of evaluation of this end point
    before as well as 7, 28 und 84 days after study drug application
    vor sowie 7, 28 und 84 Tage nach Applikation der Studienmedikation
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    immunomodulatory capacity of vitamin D3
    immunmodulatorische Wirkung von Vitamin D3
    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) No
    E.8.2.2Placebo Yes
    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 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 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
    LVLS
    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 months3
    E.8.9.1In the Member State concerned days0
    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: 40
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state40
    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
    Keine
    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 Decision2012-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-15
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