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    Summary
    EudraCT Number:2019-002781-12
    Sponsor's Protocol Code Number:2019061567
    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:2021-06-25
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-002781-12
    A.3Full title of the trial
    Using BCG vaccine to strengthen the immune system in the elderly and improve the response to influenza vaccine. A randomized clinical trial.
    Immunforsvar mod influenza
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Strengthening the protection against influenza in the elderly
    Immunforsvar mod influenza
    A.3.2Name or abbreviated title of the trial where available
    BCG-DENMARK-INFLUENZA
    A.4.1Sponsor's protocol code number2019061567
    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 Southern Denmark, Bandim Health Project
    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 supportIndependent Research Fund Denmark
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBandim Health Project
    B.5.2Functional name of contact pointChristine Stabell Benn
    B.5.3 Address:
    B.5.3.1Street AddressStudiestræde 6
    B.5.3.2Town/ cityCopenhagen K
    B.5.3.3Post code1455
    B.5.3.4CountryDenmark
    B.5.6E-mailcbenn@health.sdu.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 BCG vaccine "AJ Vaccines"
    D.2.1.1.2Name of the Marketing Authorisation holderAJ Vaccines
    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 nameBCG Vaccine "AJ Vaccines"
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBacillus Calmette-Guerin
    D.3.9.3Other descriptive nameBCG (BACILLUS CALMETTE-GUÉRIN) BACTERIA
    D.3.9.4EV Substance CodeSUB20565
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.3Concentration number2 x 10_5 to 8 x 10_5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for solution for injection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immune response to seasonal influenza vaccine
    Immunforsvarets reaktion efter sæsoninfluenzavaccine
    E.1.1.1Medical condition in easily understood language
    Immune response to seasonal influenza vaccine
    Immunforsvarets reaktion efter sæsoninfluenzavaccine
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10022005
    E.1.2Term Influenza viral infections
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10060063
    E.1.2Term Influenza serology
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We will test the effect of BCG vaccine on the specific immune response to seasonal influenza vaccination in elderly people>65 years, with the aim to improve the specific antibody response to the vaccination.

    Vi ønsker at teste, om vi forud for influenzavaccination kan styrke ældres immunforsvar med BCG vaccinen, så de reagerer lige så stærkt som yngre vokse på influenza vaccinen.
    E.2.2Secondary objectives of the trial
    We will test the effect of BCG vaccine on the immune system and health in general in elderly people>65 years, with the aim to:
    - Improve their general resistance towards infections
    - Study the effect of BCG on classical lymphocyte-dependent responses, and the induction of innate immune memory.
    Vi vil undersøge om BCG vaccination kan forebygge infektioner generelt hos ældre, samt om BCG kan aktivere immunforsvarets celler, så de bliver mere effektive til at bekæmpe infektioner.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Elderly people > 65 years and eligible for seasonal influenza vaccination. Participants must have access to ‘e-Boks’.
    E.4Principal exclusion criteria
    • Known allergy to (components of) the BCG vaccine or serious adverse events in relation to prior BCG administration
    • Previous Mycobacterium tuberculosis (M. tuberculosis) infection or known active or latent infection with M. tuberculosis or other mycobacterial species
    • Fever (>38 C) within the past 24 hours or suspicion of active viral or bacterial infection
    • Vaccination with other live attenuated vaccine within the last 4 weeks
    • Severely immunocompromised subjects. This exclusion category comprises:
    • Subjects with known infection with the human immunodeficiency virus (HIV)
    • Subjects with solid organ transplantation or bone marrow transplantation
    • Subjects under chemotherapy
    • Subjects with primary immunodeficiency
    • Treatment with any anti-cytokine therapy within the last year
    • Treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months
    • Active solid or non-solid malignancy or lymphoma within the prior two years
    • Subjects who do not have access to e-Boks.
    • Participant in BCG-DENMARK-SENIOR study
    E.5 End points
    E.5.1Primary end point(s)
    The main outcome will be change in antibody levels to influenza virus strains, comparing levels just before and 4 weeks after influenza vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks post-influenza vaccination
    E.5.2Secondary end point(s)
    Infection rate for 5 months post-randomisation.
    Association between influenza antibody level and subsequent infection rate.
    Lymphocyte-dependent responses 7 days after influenza vaccination.
    Induction of innate immune memory 14- and 42-days post-randomisation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Infection rate during 5 months post-randomisation.
    Infection rate 6 months post-randomisation.
    Lymphocyte-dependent responses 7 days after influenza vaccination.
    The induction of innate immune memory 14 and 42 days post-radomisation.
    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 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) Yes
    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 Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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
    Last visit of last subject, 6 months post-vaccination.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state300
    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 Decision2021-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-05
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