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A Study to Determine the Safety and Efficacy of SARS-CoV-2 mRNA Vaccine CVnCoV in Adults for COVID-19

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ClinicalTrials.gov Identifier: NCT04652102
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
CureVac AG

Tracking Information
First Submitted Date  ICMJE December 1, 2020
First Posted Date  ICMJE December 3, 2020
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE December 14, 2020
Estimated Primary Completion Date March 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity [ Time Frame: Day 1 to Day 393 ]
  • Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of moderate to severe COVID-19 [ Time Frame: Day 1 to Day 393 ]
  • Number of participants who experience one or more medically-attended adverse events (AEs) [ Time Frame: Day 29 to Day 211 ]
  • Intensity grading of medically-attended adverse events (AEs) per FDA toxicity grading scale [ Time Frame: Day 29 to Day 211 ]
  • Number of participants who experience one or more treatment-related medically-attended adverse events (AEs) [ Time Frame: Day 29 to Day 211 ]
  • Number of participants who experience one or more serious adverse events (SAEs) [ Time Frame: Day 29 to Day 393 ]
  • Intensity grading of serious adverse events (SAEs) per FDA toxicity grading scale [ Time Frame: Day 29 to Day 393 ]
  • Number of participants who experience one or more treatment-related serious adverse events (SAEs) [ Time Frame: Day 29 to Day 393 ]
  • Number of participants who experience one or more adverse events of special interest (AESI) [ Time Frame: Day 29 to Day 393 ]
  • Intensity grading of adverse events of special interest (AESI) per FDA toxicity grading scale [ Time Frame: Day 29 to Day 393 ]
  • Number of participants who experience one or more treatment-related adverse events of special interest (AESI) [ Time Frame: Day 29 to Day 393 ]
  • Number of participants who experience a fatal serious adverse event (SAE) [ Time Frame: Day 29 to Day 393 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} severe case of COVID-19 [ Time Frame: Day 1 to Day 393 ]
  • Number of participants with seroconversion to the nucleocapsid (N) protein of SARS-CoV-2 ≥ 15 days after the second study vaccination [ Time Frame: Days 1, 43, 211 and 393 ]
    Seroconversion is defined as detectable SARS-CoV-2 N protein antibodies in the serum of asymptomatic seronegative participants who tested seronegative on Day 1 and on Day 43.
  • Number of participants aged ≥ 61 who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity [ Time Frame: Day 1 to Day 393 ]
  • Number of participants who experience a virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} SARS-CoV-2 infection, with or without symptoms [ Time Frame: Day 1 to Day 393 ]
  • Burden of disease (BoD) based on first episodes of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} cases of COVID-19 [ Time Frame: Day 1 to Day 393 ]
  • Number of participants who experience a virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity with symptom onset at any time after the first study vaccination [ Time Frame: Post vaccination on Day 1 up to Day 393 ]
  • Number of participants with serum antibodies to SARS-CoV-2 spike (S) protein [ Time Frame: Days 1, 29, 43, 57, 120, 211 and 393 ]
    S protein will be measured by enzyme-linked immunosorbent assay (ELISA).
  • Number of participants who experience seroconversion to SARS-CoV-2 spike (S) protein [ Time Frame: Days 1, 29, 43, 57, 120, 211 and 393 ]
    S protein will be measured by enzyme-linked immunosorbent assay (ELISA). Seroconversion is defined as detectable SARS-CoV-2 S protein antibodies in the serum of participants who tested seronegative on Day 1.
  • Number of participants with serum vital neutralizing antibodies to SARS-CoV-2 virus [ Time Frame: Days 1, 29, 43, 57, 120, 211 and 393 ]
    Serum vital neutralizing antibodies to SARS-CoV-2 virus will be measured by a viral neutralizing antibody assay.
  • Number of participants who experience seroconversion to SARS-CoV-2 virus [ Time Frame: Days 1, 29, 43, 57, 120, 211 and 393 ]
    Seroconversion to SARS-CoV-2 virus will be measured by a viral neutralizing antibody assay. Seroconversion is defined as detectable SARS-CoV-2 viral neutralizing antibodies in the serum of participants who tested seronegative on Day 1.
  • Phase 2b participants only: Number of participants who experience one or more solicited local adverse events (AEs) [ Time Frame: 7 days after vaccination ]
  • Phase 2b participants only: Intensity grading of solicited local adverse events (AEs) per FDA toxicity grading scale [ Time Frame: 7 days after vaccination ]
  • Phase 2b participants only: Duration of solicited local adverse events (AEs) [ Time Frame: 7 days after vaccination ]
  • Phase 2b participants only: Number of participants who experience one or more solicited systemic adverse events (AE) [ Time Frame: 7 days after vaccination ]
  • Phase 2b participants only: Intensity grading of solicited systemic adverse events (AEs) [ Time Frame: 7 days after vaccination ]
  • Phase 2b participants only: Duration of solicited systemic adverse events (AEs) [ Time Frame: 7 days after vaccination ]
  • Phase 2b participants only: Number of participants who experience one or more unsolicited adverse events (AEs) [ Time Frame: 28 days after vaccination ]
  • Phase 2b participants only: Intensity grading of unsolicited adverse events (AEs) [ Time Frame: 28 days after vaccination ]
  • Phase 2b participants only: Number of participants who experience one or more treatment-related unsolicited adverse events (AEs) [ Time Frame: 28 days after vaccination ]
  • Number of participants who experience one or more adverse events (AEs) leading to vaccine withdrawal or trial discontinuation [ Time Frame: Day 29 to Day 393 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Safety and Efficacy of SARS-CoV-2 mRNA Vaccine CVnCoV in Adults for COVID-19
Official Title  ICMJE 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
Brief Summary

This study aims 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 participants.
  • Demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episode of virologically-confirmed moderate to severe cases of COVID-19 in SARS-CoV-2 naïve participants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Covid19
  • SARS-CoV-2
Intervention  ICMJE
  • Biological: CVnCoV
    Intramuscular (IM) injection.
  • Biological: Placebo
    Intramuscular (IM) injection.
Study Arms  ICMJE
  • Experimental: Phase 2b: CVnCoV vaccine
    Participants will be vaccinated with CVnCoV 12 µg vaccine on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
    Intervention: Biological: CVnCoV
  • Placebo Comparator: Phase 2b: Placebo
    Participants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
    Intervention: Biological: Placebo
  • Experimental: Phase 3: CVnCoV vaccine
    Participants will be vaccinated with CVnCoV 12 µg vaccine on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
    Intervention: Biological: CVnCoV
  • Placebo Comparator: Phase 3: Placebo
    Participants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2020)
36500
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2020)
40500
Estimated Study Completion Date  ICMJE March 4, 2023
Estimated Primary Completion Date March 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female participants 18 years of age or older.
  • Provide written informed consent prior to initiation of any trial procedures.
  • Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.
  • Females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation, 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.
  • Females of childbearing potential: negative urine pregnancy test (hCG) within 24 hours prior to each trial vaccination on Day 1 and Day 29.
  • Females of childbearing potential must use highly effective methods of birth control from 2 weeks 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 (IUDs);
    • Intrauterine hormone-releasing systems (IUSs);
    • Bilateral tubal occlusion;
    • Vasectomized or infertile partner;
    • Sexual abstinence {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation Methods) and withdrawal are not acceptable}.

Exclusion Criteria:

  • History of virologically-confirmed COVID-19 illness.
  • For females: pregnancy or lactation.
  • Use of any investigational or non-registered product (vaccine or drug) within 28 days preceding the administration of trial vaccine or planned use during the trial.
  • Receipt of any licensed vaccines within 28 days (for live vaccines) or 14 days (for inactivated vaccines) prior to administration of the first trial vaccine.
  • Prior administration of any investigational SARS-CoV-2 vaccine or another coronavirus (SARS-CoV, MERS-CoV) vaccine or planned used during the trial.
  • Any treatment with immunosuppressants or other immune-modifying drugs (including but not limited to corticosteroids, biologicals and methotrexate) for > 14 days total within 6 months preceding the administration of 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.
  • Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination including known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); current diagnosis of or treatment for cancer including leukemia, lymphoma, Hodgkin disease, multiple myeloma or generalized malignancy; chronic renal failure or nephrotic syndrome; and receipt of an organ or bone marrow transplant.
  • History of angioedema (hereditary or idiopathic), any anaphylactic reactions or pIMD.
  • History of allergy to any component of CVnCoV.
  • Administration of immunoglobulins or any blood products within 3 months prior to the administration of trial vaccine or planned receipt during the trial.
  • Participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the Investigator, precludes trial participation (e.g., may increase the risk of trial participation, render the participant unable to meet the requirements of the trial, or may interfere with the participant's trial evaluations). These include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses. However, those with controlled and stable cases can be included in the trial.
  • Participants with impaired coagulation or any bleeding disorder in whom an intramuscular injection or a blood draw is contraindicated.
  • Foreseeable non-compliance with the trial procedure as judged by the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Clinical Trial Information +49 69 7680587 0 clinicaltrials@curevac.com
Listed Location Countries  ICMJE Belgium,   Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04652102
Other Study ID Numbers  ICMJE CV-NCOV-004
2020-003998-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CureVac AG
Study Sponsor  ICMJE CureVac AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CureVac AG
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP