A Study to Evaluate the Safety and Immunogenicity of Vaccine CVnCoV in Healthy Adults in Germany for COVID-19
Condition: Coronavirus; Covid19; SARS-CoV-2; Severe Acute Respiratory Syndrome
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Intervention: CVnCoV Vaccine; Placebo
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; SARS; COVID; Safety; Immunogenicity

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants 18 years of age or older.

          -  Health care workers (HCWs), employees or students in clinical training.

          -  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/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.

          -  Females of childbearing potential: negative urine pregnancy test (human chorionic
             gonadotropin 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 ligation;

               -  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
             reaction.

          -  History of Potential immune-mediated disease (pIMD).

          -  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.