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    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2021-000548-23
    Sponsor's Protocol Code Number:UKE-SARS-COV-2-ST
    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:2021-05-18
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-000548-23
    A.3Full title of the trial
    A multi-center, randomized controlled, phase Ib/IIa trial to assess the safety, tolerability and immunogenicity of the candidate vaccine MVA-SARS-2-ST in adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center, randomized controlled, phase Ib/IIa trial to assess the safety, tolerability and immunogenicity of the candidate vaccine MVA-SARS-2-ST in adults
    A.4.1Sponsor's protocol code numberUKE-SARS-COV-2-ST
    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 Medical Center Hamburg-Eppendorf
    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 supportDeutsches Zentrum für Infektionsforschung (DZIF)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Hamburg-Eppendorf
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressMartinistr. 52
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20246
    B.5.3.4CountryGermany
    B.5.4Telephone number004940741051102
    B.5.5Fax number004940741058531
    B.5.6E-mailm.addo@uke.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 nameMVA-SARS-2-ST
    D.3.2Product code MVA-SARS-2-S
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 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.IMP: 2
    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 COVID-19 Vaccine Janssen suspension for injection COVID-19 vaccine (Ad26.COV2-S [recombinant])
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.1Product nameCOVID-19 Vaccine Janssen suspension for injection
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 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 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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This study is designed to evaluate the safety, tolerability and reactogenicity of intramuscular dose administrations of:
    -3 dose levels of the MVA-SARS-2-ST vaccine in healthy adults (Ib).
    -2 dose levels of the MVA-SARS-2-ST vaccine in adults in stable health condition aged 18 and older compared to active comparator(IIa Part A).
    -1 dose level of the MVA-SARS-2-ST vaccine in adults in stable health condition with previous SARS-CoV-2 infection or vaccination against COVID-19(IIa, Part B).
    E.1.1.1Medical condition in easily understood language
    This study is designed to evaluate the safety, tolerability and reactogenicity of intramuscular dose administrations of the MVA-SARS-2-ST vaccine in healthy/stable adults

    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084462
    E.1.2Term SARS-CoV-2 vaccination
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To evaluate the safety, tolerability and reactogenicity of two intramuscular dose administrations of three dose levels of the candidate MVA-SARS-2-ST vaccine in healthy adults aged 18-64 years (phase Ib).
    •To evaluate the safety, tolerability and reactogenicity of two intramuscular dose administrations of two dose levels of the candidate MVA-SARS-2-ST vaccine in adults in stable health condition aged 18 and older compared to active comparator (phase IIa Part A).
    •To evaluate the safety, tolerability and reactogenicity of one intramuscular dose administration of one dose level of the candidate MVA-SARS-2-ST vaccine in adults in stable health condition with previous SARS-CoV-2 infection or vaccination against COVID-19 (phase IIa, Part B).
    E.2.2Secondary objectives of the trial
    •To evaluate SARS-CoV-2-S-specific antibody responses in healthy adults induced by three dose levels after two administrations of MVA-SARS-2-ST (phase Ib).
    •To evaluate SARS-CoV-2-S-specific antibody responses in adults in stable health condition induced by two dose levels after two administrations of MVA-SARS-2-ST compared to active comparator (phase IIa Part A).
    •To evaluate SARS-CoV-2-S-specific antibody responses in adults in stable health condition with previous SARS-CoV-2 infection or vaccination against COVID-19 induced by one dose level after one administration of MVA-SARS-2-ST (phase IIa, Part B).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent.
    2.Healthy male and female adults aged 18 – 64 at time of informed consent (phase Ib only).
    3.Male and female adults aged 18 and above (phase IIa) at time of informed consent.
    4.Phase IIa: Either in good or stable health in the opinion of the in-vestigator. Participants may have underlying illness as long as their symptoms are medically controlled, and they are on a stable medication for the respective underlying illness for at least 8 weeks before screening and no changes are expected during the study.
    5.Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screen-ing.
    6.Female participants: non-pregnant, non-lactating with negative pregnancy test.
    7.Females who agree to comply with the applicable contraceptive requirements of the protocol.
    8.Documented previous SARS-CoV-2 infection (PCR-positive) OR documented vaccination against SARS-CoV-2 with (conditionally) licensed vaccine against COVID-19, at least 6 months prior to in-clusion into this study. (phase IIa open-label only)
    E.4Principal exclusion criteria
    1.Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live vaccines) to 6 weeks after each trial vaccination.
    2.Previous rMVA immunization.
    3.Previous immunization with investigational vaccine against COVID-19.
    4.Previous immunization with EUA/conditionally licensed vaccine against COVID-19 (not applicable to phase IIa open-label exploratory study).
    5.Evidence of active SARS-CoV-2 infection
    6.Known allergy to the components of the MVA-SARS-2-ST vaccine product or history of life-threatening reactions to vaccine containing the same substances.
    7.Known allergy to the components of the comparator vaccine (phase IIa Part A).
    8.Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
    9.Evidence in the participant's medical history or in the medical examination that might influence either the safety of the participant or the absorption, distribution, metabolism or excretion of the investigational product.
    10.Clinically relevant findings in ECG or significant thromboembolic events in medical history.
    11.Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c ≥ 7.0).
    12.Any known chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
    E.5 End points
    E.5.1Primary end point(s)
    The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST vaccine
    E.5.1.1Timepoint(s) of evaluation of this end point
    Occurrence of solicited local reactogenicity signs and symp-toms for 7 days after vaccination.
    •Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days after vaccination.
    •Occurrence of unsolicited adverse events (AE) for 28 days af-ter second vaccination.
    •Change from baseline of safety laboratory measures.
    •Occurrence of serious adverse events (SAE) throughout the study period.
    E.5.2Secondary end point(s)
    Immunogenicity
    •Humoral immunity: Magnitude of anti-SARS-CoV-2-S antibody responses.
    •Percentage of participants who seroconverted.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Magnitude of anti-SARS-CoV-2-S antibody responses on day 7, 14, 28, 35, 42, 56, 84, 168
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    COVID-19 Vaccine Janssen
    E.8.2.4Number of treatment arms in the trial7
    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 concerned6
    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 subject last visit is defined as end of trial.
    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 months7
    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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state240
    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 Decision2021-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-02
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