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    Summary
    EudraCT Number:2018-000211-25
    Sponsor's Protocol Code Number:MV-CHIK-205
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-000211-25
    A.3Full title of the trial
    Observer blinded, randomised study to investigate safety, tolerability and long-term immunogenicity of different dose regimens and formulations of MV-CHIK in healthy volunteers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial MV-CHIK-205 is designed to investigate the safety, tolerability, and long-term immunogenicity of a novel vaccine designed to protect against chikungunya virus, a mosquito-borne pathogen causing chikungunya fever throughout tropical areas worldwide.
    A.4.1Sponsor's protocol code numberMV-CHIK-205
    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 SponsorThemis Bioscience GmbH
    B.1.3.4CountryAustria
    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 supportThemis Bioscience GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThemis Bioscience GmbH
    B.5.2Functional name of contact pointClinical Study Manager
    B.5.3 Address:
    B.5.3.1Street AddressMuthgasse 11/2
    B.5.3.2Town/ cityVienna
    B.5.3.3Post codeA-1190
    B.5.3.4CountryAustria
    B.5.4Telephone number431 2367151 20
    B.5.5Fax number431 2367151 77
    B.5.6E-mailandrea.pfeiffer@themisbio.com
    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 nameMV-CHIK
    D.3.4Pharmaceutical form Lyophilisate and suspension for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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 Yes
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study is being conducted in healthy volunteers for the prophylaxis of chikungunya virus (CHIKV) infection.
    E.1.1.1Medical condition in easily understood language
    The study is being conducted in healthy volunteers for the prevention of chikungunya virus (CHIKV) infection.
    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
    To investigate immunogenicity and safety of MV-CHIK in different dose regimens, 28 days
    after one or two vaccinations
    E.2.2Secondary objectives of the trial
    • To compare immunogenicity, safety and tolerability between different doses and
    formulations of MV-CHIK during the treatment period up to day 56
    • To investigate the immunogenicity and safety of a novel liquid vaccine formulation
    • To evaluate cellular responses induced by one or two immunisations
    • To evaluate the long-term immunogenicity of MV-CHIK up to one year after the first
    MV-CHIK treatment.
    • To collect human sera for future efficacy evaluation, by passive transfer of
    anti-Chikungunya antibodies to virus susceptible non-human primates
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent obtained before any trial-related activities
    2. Healthy men or women aged 18 to 55 years on the day of consenting
    3. Ability to comprehend the full nature and purpose of the study, including possible risks
    and side effects; ability to cooperate with the investigator and to comply with the
    requirements of the entire study
    4. All female subjects must have a negative serum pregnancy test at screening
    5. Willingness not to become pregnant or to father a child during the entire study period by
    practicing reliable methods of contraception as specified in protocol section 8.11.4
    6. Availability during the duration of the trial
    E.4Principal exclusion criteria
    1. Participation in another clinical study (including exposure to an investigational medicinal
    product ore device) within one month before the screening visit or planned concurrent
    participation in another clinical study before completion of the treatment period (day 56)
    2. History of immunodeficiency, known human immunodeficiency virus (HIV) infection or
    current hepatitis B/C infection
    3. History of drug addiction including alcohol dependence within the last 2 years
    4. Inability or unwillingness to avoid intake of more than around 20g alcohol per day during
    48 hours after each vaccination (equals roughly 0.5 L beer or 0.25 L of wine)
    5. Vaccination within 4 weeks prior to first vaccination or planning to receive any non-study
    vaccine until end of treatment period (day 56)
    6. Prior receipt of any Chikungunya vaccine
    7. History of moderate or severe arthritis or arthralgia within the past 3 months prior to
    Screening Visit
    8. Recent infection within 1 week prior to Screening Visit (possibility of deferral)
    9. Blood donations including plasma donations, 90 days prior to Screening Visit and
    anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until
    end of treatment period (day 56)
    10. Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory,
    skin, haematological, endocrine, inflammatory, autoimmune or neurological diseases or
    clinically relevant abnormal laboratory values, that in the opinion of the investigator may
    interfere with the aim of the study
    11. History of neoplastic disease (excluding non-melanoma skin cancer that was
    successfully treated) within the past 5 years or a history of any haematological
    malignancy
    12. Behavioural, cognitive, or psychiatric condition that in the opinion of the investigator
    affects the ability of the participant to understand and cooperate with the study protocol
    13. History of severe adverse reactions to vaccine administration, including anaphylaxis and
    related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal
    pain to vaccines, or history of allergic reaction likely to be exacerbated by any
    component of the vaccine
    14. History of anaphylaxis to drugs or other allergic reactions, which the investigator
    considers compromising the safety of the volunteer
    15. Use of medication during 2 weeks before the first vaccination and throughout the study,
    which the investigator considers affecting the validity of the study, except hormonal
    contraception or hormonal replacement therapy in female subjects. (Prior to taking any
    medication within 72 h before study vaccination, the subject should consult the
    investigator)
    16. Use of immunosuppressive drugs like corticosteroids (excluding topical preparations)
    within 30 days prior to the first vaccination or anticipated use before completion of the
    treatment period (day 56)
    17. Receipt of blood products or immunoglobulins within 120 days prior to the Screening
    Visit or anticipated receipt of any blood product or immunoglobulin before completion of
    the treatment period (day 56)
    18. Pregnancy (positive pregnancy test at screening or during the treatment period) or
    lactation at screening, or planning to become pregnant during the treatment period
    19. Unreliable contraception methods (for details please refer to protocol section 8.11.4)
    20. Persons in a direct relationship with the sponsor, an investigator or other study team
    members. Direct dependent relationships include close relatives (i.e. children, parents,
    partner/spouse, siblings) as well as employees of the study site or the sponsor
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity 28 days after the last MV-CHIK vaccination confirmed by the presence of functional antibodies as determined by the plaque reduction neutralisation test (PRNT50).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please see E.5.1
    E.5.2Secondary end point(s)
    • Rate of solicited and unsolicited adverse events during the treatment period until day 56
    • Serious adverse events during the treatment period until study day 56
    • Immunogenicity on days 0, 28 (group A, B, C, and D), days 0, 56 (group E) and long-term
    immunogenicity on day 182 (6 Mo) and 365 (12 Mo), confirmed by the presence of
    functional antibodies as determined by the plaque reduction neutralisation test (PRNT50).
    • Measurement of anti-Chikungunya antibodies on days 0, 28, 56, 182 and 365 determined
    by enzyme linked immunosorbent assay (ELISA)
    • Measurement of anti-Measles antibodies on days 0, 28, 56 determined by enzyme linked
    immunosorbent assay (ELISA)
    • Induction of Chikungunya specific immune responses on days 0, 14, 28, 42 and 56
    determined by T-cell assay.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see E.5.2.
    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 No
    E.6.6Pharmacokinetic No
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 is one year after first dose
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    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) Yes
    F.1.2.1Number of subjects for this age range: 60
    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 state60
    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 Decision2018-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-16
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