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A Study to Evaluate the Safety and Immunogenicity of Vaccine CVnCoV in Healthy Adults in Germany for COVID-19

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ClinicalTrials.gov Identifier: NCT04674189
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
CureVac AG

Tracking Information
First Submitted Date  ICMJE December 14, 2020
First Posted Date  ICMJE December 19, 2020
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE December 23, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
  • Number of Participants with Medically-attended Adverse Events [ Time Frame: Day 29 to Day 211 ]
  • Intensity of Medically-attended Adverse Events per Investigator's Assessment [ Time Frame: Day 29 to Day 211 ]
  • Number of Participants with Medically-attended Adverse Events Considered Related to Trial Vaccine [ Time Frame: Day 29 to Day 211 ]
  • Number of Participants with One or More Serious Adverse Events (SAEs) [ Time Frame: Day 29 to Day 393 ]
  • Intensity of Serious Adverse Events (SAEs) per Investigator's Assessment [ Time Frame: Day 29 to Day 393 ]
  • Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine [ Time Frame: Day 29 to Day 393 ]
  • Number of Participants with One or More Adverse Events of Special Interest (AESIs) [ Time Frame: Day 29 to Day 393 ]
  • Intensity of Adverse Events of Special Interest (AESIs) per Investigator's Assessment [ Time Frame: Day 29 to Day 393 ]
  • Number of Participants with One or More Serious Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine [ Time Frame: Day 29 to Day 393 ]
  • Number of Participants with Death due to a Serious Adverse Event (SAE) [ Time Frame: Day 29 to Day 393 ]
  • Number of Participants with Adverse Events (AEs) Leading to Vaccine Withdrawal or Study Disctontinuation [ Time Frame: Day 29 to Day 393 ]
  • Number of Participants with Solicited Local Adverse Events [ Time Frame: 7 days after vaccination ]
  • Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale [ Time Frame: 7 days after vaccination ]
  • Duration of Solicited Local Adverse Events [ Time Frame: 7 days after vaccination ]
  • Number of Participants with Solicited Systemic Adverse Events [ Time Frame: 7 days after vaccination ]
  • Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale [ Time Frame: 7 days after vaccination ]
  • Duration of Solicited Systemic Adverse Events [ Time Frame: 7 days after vaccination ]
  • Number of Participants with Unsolicited Adverse Events [ Time Frame: 28 days after vaccination ]
  • Intensity of Unsolicited Adverse Events per the Investigator's Assessment [ Time Frame: 28 days after vaccination ]
  • Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine [ Time Frame: 28 days after vaccination ]
  • Individual SARS-CoV-2 Spike (S) Protein-Specific Antibody Levels in Serum [ Time Frame: Days 1, 29, 43, 57, 120, 211 and 393 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA).
  • Number of Participants Seroconverting for SARS-CoV-2 Spike (S) Protein Antibodies [ Time Frame: Days 1, 29, 43, 57, 120, 211 and 393 ]
    Measured using Enzyme-Linked Immunosorbent Assay (ELISA). Seroconversion is defined as detectable SARS-CoV-2 RBD of S protein antibodies in the serum of participants who tested seronegative on prior to vaccination on Day 1.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2020)
  • Number of Participants that Contract COVID-19 of Any Severity [ Time Frame: Day 1 to Day 393 ]
  • Number of Participants that Contract Mild, Moderate, Severe and Moderate to Severe COVID-19 [ Time Frame: Day 1 to Day 393 ]
  • Number of Participants Seroconverting to the Nucleocapsid (N) Protein of SARS-SoV-2 [ Time Frame: Day 1, 43, 211 and 393 ]
    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 prior to vaccination on Day 1 and Day 43.
  • Burden of Disease (BoD) Score Based on First Episodes of Virologically-confirmed Cases of COVID-19 [ Time Frame: Day 1 to Day 393 ]
  • Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum [ Time Frame: Days 1, 29, 43, 57, 120, 211 and 393 ]
    Measured by a virus neutralizing assay in a subset of participants.
  • Number of Participants Seroconverting to SARS-CoV-2 [ Time Frame: Days 1, 29, 43, 57, 120, 211 and 393 ]
    Measured by a virus neutralizing assay in a subset of participants.
  • Individual Serum Antibodies to Spike (S) Protein of SARS-CoV-2 [ Time Frame: Days 43, 57, 120, 211 and 393 ]
    Measured by a virus neutralizing assay in a subset of participants.
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 Evaluate the Safety and Immunogenicity of Vaccine CVnCoV in Healthy Adults in Germany for COVID-19
Official Title  ICMJE 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)
Brief Summary This study aims to evaluate the safety (in all participants) and reactogenicity (in a subset of participants) of CVnCoV administered as a 2-dose schedule to adult participants 18 years of age or older. The study also aims to assess antibody responses to the receptor-binding domain (RBD) of spike (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 participants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Coronavirus
  • Covid19
  • SARS-CoV-2
  • Severe Acute Respiratory Syndrome
Intervention  ICMJE
  • Biological: CVnCoV Vaccine
    Intramuscular injection
    Other Name: CV07050101
  • Drug: Placebo
    Intramuscular injection
Study Arms  ICMJE
  • Experimental: CVnCoV: Group 1, Lot 1
    Participants in Group 1 will be vaccinated with CVnCoV 12 µg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
    Intervention: Biological: CVnCoV Vaccine
  • Experimental: CVnCoV: Group 2, Lot 2
    Participants in Group 2 will be vaccinated with CVnCoV 12 µg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
    Intervention: Biological: CVnCoV Vaccine
  • Placebo Comparator: Placebo
    Participants will receive a placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm.
    Intervention: Drug: 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 14, 2020)
2520
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female participants 18 years of age or older.
  • Health care workers (HCWs), employees or students in the clinical years.
  • 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 (human chorionic gonadotropin [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 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 SARS-CoV-2 infection or SARS-CoV-2 positive serology.
  • For females: pregnancy or lactation.
  • 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.
  • Receipt of licensed vaccines within 28 days (for live vaccines) or 14 days (for inactivated vaccines) prior to the administration of trial vaccine.
  • Prior administration of any investigational SARS-CoV-2 vaccine or other coronavirus (SARS-CoV, MERS-CoV) vaccine or planned use 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), 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.
  • Active or chronic disease of, or currently on treatment for, hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • History of angioedema (hereditary or idiopathic), or a history of any anaphylactic reactions and potential immune mediated disease.
  • History of allergy to any component of CVnCoV vaccine.
  • 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 un-controlled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses.
  • Participants with impaired coagulation or any bleeding disorder in whom an intramuscular (IM) injection or a blood draw is contraindicated. However, those with controlled and stable cases can be included in the trial.
  • Foreseeable non-compliance with protocol 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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04674189
Other Study ID Numbers  ICMJE CV-NCOV-005
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 January 2021

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