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    Summary
    EudraCT Number:2020-004066-19
    Sponsor's Protocol Code Number:CV-NCOV-005
    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:2020-11-20
    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 number2020-004066-19
    A.3Full title of the trial
    COVID-19: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Clinical Study Evaluating the Safety and Immunogenicity of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adult Health Care Workers in Mainz (Germany)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Immunogenicity of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adult Health Care Workers in Mainz (Germany)
    A.3.2Name or abbreviated title of the trial where available
    Immunogenicity and Safety of CVnCoV in Adults
    A.4.1Sponsor's protocol code numberCV-NCOV-005
    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 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
    B.5.3.3Post code60325
    B.5.3.4CountryGermany
    B.5.4Telephone number+496976805870
    B.5.5Fax number+496976805872222
    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.3.9.3Other descriptive nameR9515
    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
    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
    Vaccination for prophylaxis of COVID-19 (healthy adults)
    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
    Primary Safety Objective
    • To evaluate the safety (in all subjects) and reactogenicity (in a subset of subjects) of CVnCoV administered as a 2-dose schedule to adults
    18 years of age or older.
    Primary Immunogenicity Objective
    • To assess antibody responses to the Receptor-binding domain (RBD) of S protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in adults 18 years of age or older included in a subset of subjects.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any
    severity in SARS-CoV-2 naïve subjects.
    • To describe the severity of first episodes of virologically-confirmed cases of COVID-19 in SARS-CoV-2 naïve subjects, receiving a 2-dose
    schedule of CVnCoV compared to those administered placebo.
    • To assess the efficacy of a 2-dose schedule of CVnCoV in the prevention or reduction of asymptomatic infection by SARS-CoV-2 in seronegative
    subjects, as measured by seroconversion to the N protein of the virus.
    • To assess the efficacy of a 2-dose schedule of CVnCoV in reducing the burden of disease (BoD) from COVID-19.
    Secondary Immunogenicity Objectives
    • To assess SARS-CoV-2 virus neutralizing antibody responses after 1 and 2 doses of CVnCoV in adults 18 years of age or older.
    • To assess lot-to-lot consistency of 2 CVnCoV lots, after 2 doses of CVnCoV, in adults 18 years of age or older.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects 18 years of age or older.
    2. HCWs, employees or students in the clinical years.
    3. Provide written informed consent prior to initiation of any trial procedures.
    4. Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.
    The full list of inclusion criteria is provided in the protocol.
    E.4Principal exclusion criteria
    1. History of virologically-confirmed SARS-CoV-2 infection or SARS-CoV-2 positive serology.
    2. For females: pregnancy or lactation.
    3. Use of any investigational or non-registered product (vaccine or drug) within 28 days preceding the administration of the first trial vaccine or planned use during the trial.
    4. Receipt of licensed vaccines within 28 days (for live vaccines) or 14 days (for inactivated vaccines) prior to the administration of the first trial vaccine.
    5. Prior administration of any investigational SARS-CoV-2 vaccine or another coronavirus (SARS-CoV, MERS-CoV) vaccine or planned use during the trial.
    The full list of exclusion criteria is provided in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Endpoints
    • Occurrence, intensity and relationship of medically-attended AEs collected through 6 months after the second trial vaccination in all subjects.
    • Occurrence, intensity and relationship of SAEs and AESIs collected through 1 year after the second trial vaccination in all subjects.
    • Occurrence of fatal SAEs through 1 year after the second trial vaccination in all subjects.
    • Occurrence of AEs leading to vaccine withdrawal or trial discontinuation through 1 year after the second trial vaccination in all subjects.
    • Occurrence, intensity and duration of each solicited local AE within 7 days after each trial vaccination in a subset of subjects.
    • Occurrence, intensity, duration of each solicited systemic AE within 7 days after each trial vaccination in a subset of subjects.
    • Occurrence, intensity and relationship of unsolicited AEs occurring within 28 days after each trial vaccination in a subset of subjects.

    Primary Immunogenicity Endpoint
    SARS-CoV-2 RBD of S protein antibody responses in a subset of subjects
    On Days 1, 29, 43, 57, 120, 211 and 393:
    • Serum antibodies to SARS-CoV-2 RBD of S protein.
    • Occurrence of seroconversion to SARS-CoV-2 RBD of S protein.
    - Seroconversion is defined as detectable SARS-CoV-2 RBD of S protein antibodies in the serum of subjects who tested seronegative at baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    as specified in the endpoints
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
    • Occurrence of first episodes of virologically-confirmed (RT-PCR) cases of COVID-19 of any severity meeting the case definition for the efficacy analysis.
    • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 meeting the case definition for the efficacy analysis by severity (mild, moderate, severe and moderate to severe COVID-19) as defined in Appendix 3 and Appendix 4.
    • Occurrence of seroconversion to the N protein of SARS-CoV-2 ≥ 15 days following the second trial vaccination in asymptomatic
    seronegative subjects.
    - Seroconversion is defined as detectable SARS-CoV-2 N Protein antibodies in the serum of subjects on Day 211 and/or Day 393 of the trial, who tested seronegative at Day 1 (baseline) and Day 43 (i.e. at the 2 testing time points prior to 15 days after the second trial vaccination).
    • BoD scores calculated based on first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 of any severity meeting the case definition for the efficacy Analysis.
    - BoD #1 – no disease (not infected or asymptomatic infection) = 0; mild or moderate disease = 1; severe disease = 2.
    - BoD #2 – no disease (not infected or asymptomatic infection) = 0; disease without hospitalization = 1; disease with hospitalization = 2; death = 3

    Secondary Immunogenicity Endpoints
    SARS-CoV-2 virus neutralizing antibody responses in a subset of subjects
    On Days 1, 29, 43, 57, 120, 211 and 393:
    • Serum neutralizing antibodies to SARS-CoV-2 virus, as measured by a virus neutralizing assay.
    • Occurrence of seroconversion to SARS-CoV-2 virus, as measured by a virus neutralizing assay.
    - Seroconversion is defined as detectable SARS-CoV-2 Virus neutralizing antibodies in the serum of subjects who tested seronegative at baseline.
    Lot-to-lot consistency of 2 CVnCoV lots, as measured by SARS-CoV-2 RBD of S protein antibody responses in a subset of subjects
    On Days 43, 57, 120, 211 and 393:
    • Serum antibodies to SARS-CoV-2 RBD of S protein.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    observer-blinded
    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 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 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 years1
    E.8.9.1In the Member State concerned months4
    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: 2500
    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 state2520
    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 Decision2020-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-08
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