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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2020-003998-22
    Sponsor's Protocol Code Number:CV-NCOV-004
    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:2020-11-19
    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 number2020-003998-22
    A.3Full title of the trial
    COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older
    A.3.2Name or abbreviated title of the trial where available
    HERALD
    A.4.1Sponsor's protocol code numberCV-NCOV-004
    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 number00496976805872222
    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
    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
    OBJECTIVES FOR THE RANDOMIZED OBSERVE-BLINDED PHASE:
    Primary Efficacy Objectives
    • To demonstrate 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.

    Primary Safety Objectives
    • To evaluate the safety of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older.
    • To evaluate the reactogenicity of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older participating in Phase 2b of the trial.

    OBJECTIVES FOR THE OPEN-LABEL PHASE:
    Primary Safety Objective:
    • To evaluate safety in all subjects ≥ 18 years of age remaining in the trial after unblinding
    E.2.2Secondary objectives of the trial
    SECONDARY OBJECTIVES FOR THE RANDOMIZED OBSERVE-BLINDED PHASE:
    Key Secondary Efficacy Objectives
    • To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed moderate to severe cases of COVID-19 in SARS CoV-2 naïve subjects.
    • To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed severe cases of COVID-19 in SARS-CoV-2 naïve subjects.
    • To demonstrate 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 caused by "wild type" (i.e., WT/D614G lineages A.1/B.1 without the variant of concern [VOC] B.1.1.7 [Alpha], B.1.351 [Beta], B.1.429 [Epsilon]) and "UK" (B.1.1.7 [Alpha]) SARS CoV 2 strains in SARS CoV 2 naïve subjects.

    SECONDARY OBJECTIVES FOR THE OPEN-LABEL PHASE:
    None.

    For full list see protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    INCLUSION CRITERIA FOR ALL SUBJECTS:
    1. Male or female subjects 18 years of age or older.
    2. Be willing and able to provide written informed consent prior to initiation of any trial procedures
    3. Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.
    4. Females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥ 12 consecutive months prior to screening (Day 1)} without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status.
    5. Females of childbearing potential: negative pregnancy test {human chorionic gonadotropin (hCG)} within 24 hours prior to each trial vaccination on Day 1 and Day 29.

    Full list of inclusion criteria is provided in the protocol.

    ROLL-OVER CRITERIA FOR THE OPEN-LABEL PHASE:
    1. Subjects must have received at least 1 dose of CVnCoV during the randomized observer blinded phase.
    2. Subjects must provide additional written informed consent to be eligible for the open label phase.
    • Cohort A: CVnCoV-AV
    3. Subjects of the CVnCoV treatment arm who received or will receive any AV as standard of care through their national vaccination program.
    • Cohort B: CVnCoV only
    3. Subjects have not received any vaccination with any other investigational/authorized SARS CoV-2 vaccine or another coronavirus (SARS CoV, MERS-CoV) vaccine
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA FOR ALL SUBJECTS:
    1. History of virologically-confirmed COVID-19 illness.
    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 or any other 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.

    Full list of exclusion criteria is provided in the protocol

    ROLL-OVER CRITERIA FOR THE OPEN-LABEL PHASE:
    1. Subjects must have received at least 1 dose of CVnCoV during the randomized observer blinded phase.
    2. Subjects must provide additional written informed consent to be eligible for the open label phase.
    • Cohort A: CVnCoV-AV
    3. Subjects of the CVnCoV treatment arm who received or will receive any AV as standard of care through their national vaccination program.
    • Cohort B: CVnCoV only
    3. Subjects have not received any vaccination with any other investigational/authorized SARS CoV-2 vaccine or another coronavirus (SARS CoV, MERS-CoV) vaccine
    E.5 End points
    E.5.1Primary end point(s)
    END POINTS FOR THE RANDOMIZED OBSERVE-BLINDED PHASE:
    Primary Efficacy Endpoints
    • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 of any severity meeting the case definition for the primary efficacy analysis.

    Primary Safety Endpoints
    All safety endpoints will be analyzed in all subjects, in subjects seronegative at baseline, and in subjects seropositive at baseline.
    • 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 throughout the trial in all subjects.
    • Occurrence of fatal SAEs throughout the trial in all subjects.
    • Occurrence, intensity, and duration of each solicited local AE within 7 days after each trial vaccination in Phase 2b subjects.
    • Occurrence, intensity, duration of each solicited systemic AE within 7 days after each trial vaccination in Phase 2b subjects.
    • Occurrence, intensity and relationship of unsolicited AEs occurring within 28 days after each trial vaccination in Phase 2b subjects.
    • Occurrence of AEs leading to vaccine withdrawal or trial discontinuation throughout the trial in all subjects.

    ENDPOINTS FOR THE OPEN-LABEL PHASE:
    • Occurrence, intensity, and relationship to CVnCoV of SAEs and AESIs collected throughout the trial until the end of trial (EOT).
    • Occurrence of fatal SAEs throughout the trial until EOT.
    • Only for Cohort A: CVnCoV-AV: Occurrence of AEs leading to AV withdrawal or trial discontinuation after the first dose with an AV in the open-label phase until EOT

    Open-label Exploratory Endpoint
    • Occurrence of first episodes of symptomatic virologically-confirmed (RT-PCR positive) cases of COVID-19 of any severity as assessed by the Investigator.
    Any further modifications to endpoints in the open-label phase will be described in the statistical analysis plan (SAP).
    E.5.1.1Timepoint(s) of evaluation of this end point
    as specified in the endpoints
    E.5.2Secondary end point(s)
    SECONDARY END POINTS FOR THE RANDOMIZED OBSERVE-BLINDED PHASE ONLY:
    Key Secondary Efficacy Endpoints
    • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of moderate to severe COVID-19 meeting the case definition for the primary efficacy analysis (moderate and severe COVID-19 disease is defined in Appendix 3 and Appendix 4).
    • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) severe cases of COVID-19 (meeting the case definition for the primary efficacy analysis (severe COVID-19 disease defined in Appendix 3).
    •Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 of any severity meeting the case definition due to infection with "wild type" (i.e., WT/D614G lineages A.1/B.1 without VOC B.1.1.7 [Alpha], B.1.351 [Beta], B.1.429 [Epsilon]) and "UK" (B.1.1.7 [Alpha]) SARS CoV 2 strains in SARS CoV 2 naïve subjects.

    Secondary Immunogenicity Endpoints (Phase 2b Immunogenicity Subset)
    SARS-CoV-2 (RBD) of S protein antibody responses
    On Days 1, 29, 43, 120 and 393:
    • Serum antibodies to SARS-CoV-2 S protein.
    • Occurrence of seroconversion to SARS-CoV-2 S protein.
    Seroconversion is defined as detectable SARS-CoV-2 S protein antibodies in the serum of subjects who tested seronegative at baseline.

    SARS-CoV-2 viral neutralizing antibody responses
    On Days 1, 29, 43, 120 and 393:
    • Serum neutralizing antibodies to SARS-CoV-2 virus, as measured by a viral neutralizing antibody assay.
    • Occurrence of seroconversion to SARS-CoV-2 virus, as measured by a viral neutralizing antibody assay.
    Seroconversion is defined as detectable SARS-CoV-2 viral neutralizing antibodies in the serum of subjects who tested seronegative at baseline.

    Full list of secondary end points is provided in the protocol.
    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 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) 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
    Randomized observer-blinded followed by an Open Label Phase
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Colombia
    Dominican Republic
    Mexico
    Panama
    Peru
    Argentina
    Belgium
    Germany
    Netherlands
    Spain
    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 years
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months13
    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: 30000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6500
    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 state3000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8500
    F.4.2.2In the whole clinical trial 36500
    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 Decision2020-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-03
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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