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

Inclusion Criteria:

- Healthy male and female participants ≥18 years of age. A healthy participant is
defined as an individual who is in good general health, according to the
Investigator's assessment. Chronic health conditions are acceptable if the condition
is considered well controlled with treatment according to the discretion of the
Investigator.

- Expected to be compliant with protocol procedures and available for clinical follow-up
through the last planned visit.

- Participants are able to understand and willing to provide informed consent.

- Physical examination without clinically significant findings according to the
Investigator's assessment.

- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2.

- Female participants of childbearing potential: at the time of enrollment, negative
human chorionic gonadotropin (hCG) pregnancy test (serum) for female participants
presumed to be of childbearing potential on the day of enrollment. On Day 1
(pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was
performed more than 3 days before).

- Female participants 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;

- Intrauterine hormone-releasing systems;

- Bilateral tubal occlusion;

- Vasectomized partner;

- Sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal
and post-ovulation methods] and withdrawal are not acceptable).

- Male participants should be instructed not to get their partners pregnant until 3
months after the last administration.

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.