A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19

Exclusion Criteria

• •Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period.
• •Receipt of any other vaccines within 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration (primary dose or booster dose).
• •Receipt of any investigational or licensed/authorized SARS-CoV-2 or other coronavirus vaccine prior to the administration of the trial vaccine.
• •Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied, inhaled, or intranasal steroids.
• •Use of hormonal therapy for gender reassignment.
• •Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection, and hepatitis C virus infection.
• •History of immune-mediated or autoimmune disease.
• •History of angioedema (known C1 inhibitor deficiency).
• •History of anaphylaxis or allergy to any component of CVnCoV or aminoglycoside antibiotics.
• •History of or current alcohol and/or drug abuse.
• •Participants who are active smokers, were active smokers within the last year (including any vaping in the last year), or have a total smoking history ≥10 pack years. A pack year is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.
• •History of virologically-confirmed Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or COVID-19 disease or known exposure (without any personal protective equipment) to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within the past 2 weeks.
• •Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine.
• •Presence or evidence of significant uncontrolled acute or chronic medical or psychiatric illness. Significant medical or psychiatric illnesses include but are not limited to:
• •* Uncontrolled respiratory disease (e.g., chronic obstructive pulmonary disease, asthma), including use of the following asthma medications: intravenous corticosteroids, leukotriene modifiers, biologics.
• •* Uncontrolled cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease, history of stroke, peripheral artery disease, pulmonary embolism).
• •* History of myocarditis or pericarditis as an adult.
• •* Diabetes mellitus (insulin-dependent).
• •* Uncontrolled neurological disorders or Guillain-Barré syndrome or history of seizure, except for febrile seizures during childhood.
• •* Current or past malignancy, unless completely resolved without sequelae for \>5 years.
• •Foreseeable non-compliance with protocol, as judged by the Investigator.
• •For female participants: pregnancy or lactation.
• •Participants with impaired coagulation or any bleeding disorder in whom an intramuscular injection or a blood draw is contraindicated. This includes participants on treatment with anticoagulants (e.g., vitamin K antagonists, novel oral anticoagulants, and heparin). Use of platelet aggregation inhibitors is not exclusionary.
• •Participants employed by the Sponsor, Investigator, or trial site, or relatives of research staff working on this trial.
• •Participants considered at the Investigator's discretion to be at increased risk of exposure to COVID-19 disease.