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    Summary
    EudraCT Number:2020-001675-33
    Sponsor's Protocol Code Number:VPM1002-DE-3.07CoV
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-17
    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 - PEI
    A.2EudraCT number2020-001675-33
    A.3Full title of the trial
    A phase III, randomized, double-blind, placebo-controlled, multicentre, clinical trial to assess the efficacy and safety of VPM1002 in reducing hospital admissions and/or severe respiratory infectious diseases in elderly in the SARS-CoV-2 pandemic by modulating the immune system
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate whether vaccination with VPM1002 can reduce elderly people's days with severe respiratory infectious diseases at hospital and/or at home
    A.4.1Sponsor's protocol code numberVPM1002-DE-3.07CoV
    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 SponsorVakzine Projekt Management GmbH
    B.1.3.4CountryGermany
    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 supportVakzine Projekt Management GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVakzine Projekt Management GmbH
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressMellendorfer Str. 9
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number+495111699080
    B.5.6E-mailinfo@vakzine-manager.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 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 nameVPM1002
    D.3.4Pharmaceutical form Lyophilisate for suspension 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 INNVPM1002
    D.3.9.2Current sponsor codeVPM1002
    D.3.9.3Other descriptive nameRecombinant Mycobacterium bovis rBCGΔureC::hly; VPM1002
    D.3.9.4EV Substance CodeSUB207677
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2000000 to 8000000
    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 Yes
    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 placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    infectious respiratory diseases (e.g. COVID-19)
    E.1.1.1Medical condition in easily understood language
    Infectious diseases of the lung (e.g. COVID-19, which is caused by coronavirus SARS-CoV-2)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10024970
    E.1.2Term Respiratory tract infections
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the reduction of days with severe respiratory infectious diseases at hospital and/or at home in elderly subjects during the pandemic of SARS-CoV-2
    E.2.2Secondary objectives of the trial
    To assess the reduction of disease severity, the duration of hospital admission, intensive care unit (ICU) admission, or death in elderly subjects during the pandemic of SARS-CoV-2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female adult (≥ 60 years)
    2. Subject is contractually capable, able to understand information on study
    and has signed informed consent sheet
    3. Subject has access to an internet-enabled electronic device
    E.4Principal exclusion criteria
    1. Known active or latent Mycobacterium tuberculosis infection
    2. Fever (> 38 °C) or respiratory tract infection within the past 24 hours
    3. Current active viral or bacterial infection
    4. Expected vaccination during the study period; vaccinations against influenza and pneumococcal disease are allowed with ≥ 4 weeks between these vaccinations and the trial vaccination
    5. Participation in another interventional study within 30 days before screening and during this study
    6. Known hypersensitivity or allergy to (components of) the VPM1002 vaccine or serious adverse reactions to prior Bacille Calmette-Guérin (BCG) administration
    7. Severely immunocompromised subjects, including:
    (a) subjects with known infection by the human immunodeficiency
    virus (HIV-1);
    (b) subjects with solid organ transplantation;
    (c) subjects with bone marrow transplantation;
    (d) subjects under chemotherapy, immunotherapy, or radiotherapy;
    (e) subjects with primary immunodeficiency;
    (f) treatment with any anti-cytokine therapies;
    (g) treatment with oral or intravenous steroids defined as daily doses
    of 10 mg prednisone or equivalent for longer than 3 months, or
    likely use of oral or intravenous steroids in the next 4 weeks;
    8. History of malignancies, unless the subject has been free of the disease for ≥ 2 years; exception: subjects with adequately treated basal or squamous cell cancer or other localized non-melanoma skin cancer and adequately treated carcinoma in situ of the cervix may participate in the trial
    9. Previous positive SARS-CoV-2 test result
    10. Person is an employee of the sponsor, a relative of the sponsor or investigator, or is employed in the same department as the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Number of days with severe respiratory disease at hospital and/or at home
    E.5.1.1Timepoint(s) of evaluation of this end point
    From day 0 to day 240
    E.5.2Secondary end point(s)
    • Cumulative incidence of hospital admissions
    • Cumulative incidence of documented SARS-CoV-2 infection
    • Number of days with self-reported fever (≥ 38 ºC)
    • Number of days with self-reported acute respiratory symptoms
    • Cumulative incidence of self-reported acute respiratory symptoms
    • Cumulative incidence of death for any reason
    • Cumulative incidence of death due to documented SARS-CoV-2 infection
    • Cumulative incidence of ICU admission for any reason
    • Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection
    • Cumulative incidence of hospital admission due to documented SARS-CoV-2 infection
    E.5.2.1Timepoint(s) of evaluation of this end point
    From day 0 to day 240
    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) 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 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 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 concerned20
    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
    Last visit of the last subject
    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 months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1538
    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 state2038
    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)
    There is no particular plan for treatment or care of the clinical trial subjects after their participation in this clinical trial has ended.
    Subjects with confirmed SARS-CoV-2 infection (with or without symptoms) will be followed for at least 6 weeks (from the date of test result), independent of the total trial duration. All safety data that are assessed during the weekly assessment after vaccination will also be assessed during these 6 weeks.
    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 Decision2020-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-12
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