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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-004070-22
    Sponsor's Protocol Code Number:CV-NCOV-003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-12
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-004070-22
    A.3Full title of the trial
    COVID-19: A Phase 3 multicenter clinical trial to evaluate the safety, reactogenicity and immunogenicity of the investigational SARS-CoV-2 mRNA vaccine CVnCoV in adults 18 years of age and above with co-morbidities
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARSCoV-2 mRNA Vaccine CVnCoV in Adults With Co-morbidities
    A.4.1Sponsor's protocol code numberCV-NCOV-003
    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 SponsorCureVac AG
    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 supportBMBF (Bundesministerium für Bildung und Forschung)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportCureVac AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCureVac AG
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressSchumannstr. 27
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60325
    B.5.3.4CountryGermany
    B.5.4Telephone number00496976805870
    B.5.5Fax number0049697680587 2222
    B.5.6E-mailclinicaltrials@curevac.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 nameCVnCoV
    D.3.2Product code CV07050101
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZorecimeran
    D.3.9.2Current sponsor codeR9515
    D.3.9.4EV Substance CodeSUB214710
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vaccination for prophylaxis of COVID-19 (adults with co morbidities)
    E.1.1.1Medical condition in easily understood language
    Prophylactic vaccine against COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084464
    E.1.2Term COVID-19 immunization
    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 and reactogenicity profile after 1 and 2 dose administrations of CVnCoV.
    • To evaluate the humoral immune responses 14 days after 2 dose administrations of CVnCoV.
    E.2.2Secondary objectives of the trial
    Secondary
    •To evaluate the humoral immune responses after 1 and 2 dose administrations of CVnCoV at different time points during the trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects ≥18 years of age with 1 or more co-morbidities as defined by the case definitions specified in the section “Case definitions co-morbidities”.
    2. For the co-morbidities chronic kidney disease, COPD, chronic cardiovascular disease and diabetes mellitus, the first 25 subjects per co-morbidity should include only mild to moderate cases as described in the section “Case definitions co-morbidities”. Thereafter, more severe conditions may be recruited (see the section “Overall design”) following iSRC and DSMB Chair approval.
    3. Subject has no overt clinical signs or symptoms of COVID-19.
    4. Subject has to sign the informed consent form (ICF) before any study procedures.
    5. Subjects with a life expectancy of at least 1 year as per the Investigators assessment.
    6. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
    7. Physical examination without acute clinically significant findings according to the Investigator’s assessment.
    8. Females: At the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre vaccination): negative urine pregnancy test (hCG), (only required if serum pregnancy test was performed more than 3 days before).
    Note: Women that are postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause) or permanently sterilized will be considered as not having reproductive potential.
    9. Females of childbearing potential must use highly effective methods of birth control from 1 month before the first administration of the trial vaccine until 3 months following the last administration.
    The following methods of birth control are considered highly effective when used consistently and correctly:
    • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal);
    • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable);
    • Intrauterine devices;
    • Intrauterine hormone-releasing systems;
    • Bilateral tubal occlusion;
    • Vasectomized partner;
    • Same sex relationships.
    Sexual abstinence [periodic abstinence (e.g., calendar, ovulation symptothermal and post-ovulation methods)] and withdrawal are not acceptable methods.
    E.4Principal exclusion criteria
    1. A previous clinical and laboratory-confirmed diagnosis of COVD-19 within the last six months prior to screening.
    2. Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period.
    3. Receipt of any other vaccines within 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration. Planned vaccination with an inactivated influenza vaccine is permitted.
    4. Receipt of any investigational, authorized or licensed SARS-CoV-2, other coronavirus vaccine or any other lipid nanoparticle (LNP) containing mRNA vaccine prior to the administration of the trial vaccine. For authorized or licensed SARS-CoV-2: planned administration during the trial up to 6 weeks after the foreseen date of second dose administration of CVnCoV.
    5. Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) for >14 days in total within 6 months prior to the administration of the trial vaccine or planned use during the trial. For corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. The use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted.
    Note: This exclusion does not apply to the renal transplant cases and is at the Investigator’s discretion for subjects with other co-morbidities (e.g., COPD).
    6. Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, excluding the co-morbidities specified in the section “Case definitions co-morbidities”.
    (Subjects with chronic HIV infection with controlled Hep B infection with therapy or aviremic Hep C may be eligible for the trial, based on the Investigator’s judgment).
    7. History of immune mediated or autoimmune disease.
    8. History of anaphylaxis or allergy to any component of CVnCoV or aminoglycoside antibiotics.
    9. History of or current alcohol and/or drug abuse.
    10. History of confirmed SARS or MERS disease.
    11. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine.
    12. Presence of evidence of significant uncontrolled acute or chronic medical or psychiatric illness, excluding the co-morbidities specified in the section “Case definitions co-morbidities”. Significant medical or psychiatric illnesses include but are not limited to:
    • Uncontrolled respiratory disease
    • Uncontrolled neurological disorders or Guillain-Barré syndrome or history of seizure, except for febrile seizures during childhood.
    • Current or past malignancy, unless completely resolved without sequelae for >5 years.
    13. Foreseeable non-compliance with protocol, as judged by the Investigator.
    14. For female subjects: pregnancy or lactation
    15. Subjects with impaired coagulation or any bleeding disorder in whom an intramuscular injection or a blood draw is contraindicated. This includes subjects on treatment with anticoagulants (e.g., vitamin K antagonists, novel oral anticoagulants, and heparin). Use of platelet aggregation inhibitors is not exclusionary. However, use of anticoagulants is accepted in certain co-morbid conditions according to the clinical Investigator’s judgment and if the INR remains ≤3.
    16. Subjects employed by the Sponsor, Investigator, or trial site, or relatives of research staff working on this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Primary

    Safety
    • The frequency, intensity, and duration of solicited local AEs on each vaccination day and the following 7 days.
    • The frequency, intensity, duration, and relationship to trial vaccination of solicited systemic AEs on each vaccination day and the following 7 days.
    • The occurrence, intensity and relationship to trial vaccination of unsolicited AEs on each vaccination day and the following 28 days.
    • The occurrence and relationship to trial vaccination of SAEs and AESIs throughout the trial.
    Immunogenicity
    On Day 43:
    • The proportion of subjects seroconverting for SARS-CoV-2 S protein receptor-binding domain (RBD) antibodies, as measured by an immunoassay.
    • Individual SARS-CoV-2 S protein RBD-specific antibody levels in serum, as measured an immunoassay.
    • Geometric mean titers (GMTs) of serum SARS-CoV-2 S protein RBD antibodies, as measured by an immunoassay.
    • In a subset of subjects*: the proportion of subjects seroconverting for SARS-CoV-2 neutralizing antibodies, as measured by an activity assay.
    • In a subset of subjects*: individual SARS-CoV-2 neutralizing antibody levels in serum, as measured by an activity assay.
    • In a subset of subjects*: GMTs of serum SARS-CoV-2 neutralizing antibodies, as measured by an activity assay.
    E.5.1.1Timepoint(s) of evaluation of this end point
    as specified in the endpoints
    E.5.2Secondary end point(s)
    Secondary

    On Day 29, Day 120, Day 211 and Day 393:
    • The proportion of subjects seroconverting for SARS-CoV-2 S protein RBD antibodies, as measured by an immunoassay.
    • Individual SARS-CoV-2 S protein RBD-specific antibody levels in serum, as measured by an immunoassay.
    • GMTs of serum SARS-CoV-2 S protein RBD antibodies, as measured by an immunoassay.
    In a subset of subjects*, on Day 29 and Day 120:
    • The proportion of subjects seroconverting for SARS-CoV-2 neutralizing antibodies, as measured by an activity assay.
    • Individual SARS-CoV-2 neutralizing antibody levels in serum, as measured by an activity assay.
    • GMTs of serum SARS-CoV-2 neutralizing antibodies, as measured by an activity assay.
    E.5.2.1Timepoint(s) of evaluation of this end point
    as specified in the endpoints
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    reactogenicity and immunogenicity
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    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: 840
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 360
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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 state1200
    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 Decision2021-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-21
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