Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
    •
    EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43855   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number: 2020-003998-22
    Sponsor's Protocol Code Number: CV-NCOV-004
    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: 2020-11-19
    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.1 Member State Concerned Germany - PEI
    A.2 EudraCT number 2020-003998-22
    A.3 Full 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.3.1 Title 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.3.2 Name or abbreviated title of the trial where available
    HERALD
    A.4.1 Sponsor's protocol code number CV-NCOV-004
    A.7 Trial is part of a Paediatric Investigation Plan No
    A.8 EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1 Name of Sponsor CureVac AG
    B.1.3.4 Country Germany
    B.3.1 and B.3.2 Status of the sponsor Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1 Name of organisation providing support BMBF (Bundesministerium für Bildung und Forschung)
    B.4.2 Country Germany
    B.4.1 Name of organisation providing support CureVac AG
    B.4.2 Country Germany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1 Name of organisation CureVac AG
    B.5.2 Functional name of contact point Clinical Trial Information
    B.5.3 Address:
    B.5.3.1 Street Address Schumannstr. 27
    B.5.3.2 Town/ city Frankfurt am Main
    B.5.3.3 Post code 60325
    B.5.3.4 Country Germany
    B.5.4 Telephone number 00496976805870
    B.5.5 Fax number 00496976805872222
    B.5.6 E-mail clinicaltrials@curevac.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3 IMP Role Test
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1 IMP to be used in the trial has a marketing authorisation No
    D.2.5 The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1 Orphan drug designation number
    D.3 Description of the IMP
    D.3.1 Product name CVnCoV
    D.3.2 Product code CV07050101
    D.3.4 Pharmaceutical form Solution for injection
    D.3.4.1 Specific paediatric formulation No
    D.3.7 Routes of administration for this IMP Intramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8 INN - Proposed INN Zorecimeran
    D.3.9.2 Current sponsor code R9515
    D.3.9.4 EV Substance Code SUB214710
    D.3.10 Strength
    D.3.10.1 Concentration unit g/l gram(s)/litre
    D.3.10.2 Concentration type equal
    D.3.10.3 Concentration number 1
    D.3.11 The IMP contains an:
    D.3.11.1 Active substance of chemical origin No
    D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3 Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1 Somatic cell therapy medicinal product No
    D.3.11.3.2 Gene therapy medical product No
    D.3.11.3.3 Tissue Engineered Product No
    D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5 Radiopharmaceutical medicinal product No
    D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7 Plasma derived medicinal product No
    D.3.11.8 Extractive medicinal product No
    D.3.11.9 Recombinant medicinal product No
    D.3.11.10 Medicinal product containing genetically modified organisms No
    D.3.11.11 Herbal medicinal product No
    D.3.11.12 Homeopathic medicinal product No
    D.3.11.13 Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1 Is a Placebo used in this Trial? Yes
    D.8.3 Pharmaceutical form of the placebo Solution for injection
    D.8.4 Route of administration of the placebo Intramuscular use
    D.8 Placebo: 2
    D.8.1 Is a Placebo used in this Trial? Yes
    D.8.3 Pharmaceutical form of the placebo Solution for injection
    D.8.4 Route of administration of the placebo Intramuscular use
    D.8 Placebo: 3
    D.8.1 Is a Placebo used in this Trial? Yes
    D.8.3 Pharmaceutical form of the placebo Solution for injection
    D.8.4 Route of administration of the placebo Intramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1 Medical condition(s) being investigated
    Vaccination for prophylaxis of COVID-19 (healthy adults)
    E.1.1.1 Medical condition in easily understood language
    Prophylactic vaccine against COVID-19
    E.1.1.2 Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2 Version 23.1
    E.1.2 Level LLT
    E.1.2 Classification code 10084464
    E.1.2 Term COVID-19 immunization
    E.1.2 System Organ Class 100000004865
    E.1.3 Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1 Main 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.2.2 Secondary 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.2.3 Trial contains a sub-study No
    E.3 Principal 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.4 Principal 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.5.1 Primary end point(s)
    END POINTS FOR THE RANDOMIZED OBSERVE-BLINDED PHASE:
    Primary Efficacy Endpoints
    • Occurrence of first episodes of virologically-confirmed {reverse transcription polymerase chain reaction (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.5.1.1 Timepoint(s) of evaluation of this end point
    as specified in the endpoints
    E.5.2 Secondary 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 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 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 211:
    • 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.

    SARS-CoV-2 viral neutralizing antibody responses on Days 1, 29, 43, 120, and 211:
    • Serum viral 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.5.2.1 Timepoint(s) of evaluation of this end point
    as specified in the endpoints
    E.6 and E.7 Scope of the trial
    E.6 Scope of the trial
    E.6.1 Diagnosis No
    E.6.2 Prophylaxis No
    E.6.3 Therapy No
    E.6.4 Safety Yes
    E.6.5 Efficacy Yes
    E.6.6 Pharmacokinetic No
    E.6.7 Pharmacodynamic No
    E.6.8 Bioequivalence No
    E.6.9 Dose response No
    E.6.10 Pharmacogenetic No
    E.6.11 Pharmacogenomic No
    E.6.12 Pharmacoeconomic No
    E.6.13 Others No
    E.7 Trial type and phase
    E.7.1 Human pharmacology (Phase I) No
    E.7.1.1 First administration to humans No
    E.7.1.2 Bioequivalence study No
    E.7.1.3 Other No
    E.7.1.3.1 Other trial type description
    E.7.2 Therapeutic exploratory (Phase II) Yes
    E.7.3 Therapeutic confirmatory (Phase III) Yes
    E.7.4 Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1 Controlled Yes
    E.8.1.1 Randomised Yes
    E.8.1.2 Open No
    E.8.1.3 Single blind No
    E.8.1.4 Double blind No
    E.8.1.5 Parallel group No
    E.8.1.6 Cross over No
    E.8.1.7 Other Yes
    E.8.1.7.1 Other trial design description
    Randomized observer-blinded followed by an Open Label Phase
    E.8.2 Comparator of controlled trial
    E.8.2.1 Other medicinal product(s) No
    E.8.2.2 Placebo Yes
    E.8.2.3 Other No
    E.8.2.4 Number of treatment arms in the trial 2
    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.8.4.1 Number of sites anticipated in Member State concerned 3
    E.8.5 The trial involves multiple Member States Yes
    E.8.5.1 Number of sites anticipated in the EEA 13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1 Trial being conducted both within and outside the EEA Yes
    E.8.6.2 Trial being conducted completely outside of the EEA No
    E.8.6.3 If 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.8.7 Trial 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.8.9.1 In the Member State concerned years
    E.8.9.1 In the Member State concerned months 13
    E.8.9.1 In the Member State concerned days
    E.8.9.2 In all countries concerned by the trial months 13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1 Trial has subjects under 18 No
    F.1.1.1 In Utero No
    F.1.1.2 Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3 Newborns (0-27 days) No
    F.1.1.4 Infants and toddlers (28 days-23 months) No
    F.1.1.5 Children (2-11years) No
    F.1.1.6 Adolescents (12-17 years) No
    F.1.2 Adults (18-64 years) Yes
    F.1.2.1 Number of subjects for this age range: 30000
    F.1.3 Elderly (>=65 years) Yes
    F.1.3.1 Number of subjects for this age range: 6500
    F.2 Gender
    F.2.1 Female Yes
    F.2.2 Male Yes
    F.3 Group of trial subjects
    F.3.1 Healthy volunteers Yes
    F.3.2 Patients No
    F.3.3 Specific vulnerable populations Yes
    F.3.3.1 Women of childbearing potential not using contraception No
    F.3.3.2 Women of child-bearing potential using contraception Yes
    F.3.3.3 Pregnant women No
    F.3.3.4 Nursing women No
    F.3.3.5 Emergency situation No
    F.3.3.6 Subjects incapable of giving consent personally No
    F.3.3.7 Others No
    F.4 Planned number of subjects to be included
    F.4.1 In the member state 3000
    F.4.2 For a multinational trial
    F.4.2.1 In the EEA 8500
    F.4.2.2 In 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 Decision 2020-12-11
    N. Ethics Committee Opinion of the trial application Favourable
    N. Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N. Date of Ethics Committee Opinion 2020-11-24
    P. End of Trial
    P. End of Trial Status Completed
    P. Date of the global end of the trial 2022-06-03
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 23 13:32:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA