A Study to Assess the Safety and Immunogenicity of the Coronavac Vaccine Against COVID-19

Inclusion Criteria:

- Adults 18 years of age or older;

- Agree with study procedures after reading and signing the Informed Consent Form

Exclusion Criteria:

- Pregnancy (confirmed by positive β-hCG test), breastfeeding and / or expressing
intention to have sexual practices with reproductive potential without using
contraceptive methods in the three months following vaccination

- Evidence of uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease,
according to anamnesis or physical examination. Significant changes in treatment or
hospitalizations due to worsening of the condition in the last three months are
indicators of uncontrolled disease;

- Diseases with impaired immune system including: neoplasms (except basal cell
carcinoma), congenital or acquired immunodeficiencies and autoimmune diseases not
controlled according to anamnesis or physical examination. Significant changes in
treatment or hospitalizations due to worsening of the condition in the last three
months are indicators of uncontrolled disease;

- Behavioral, cognitive or psychiatric illness that, in the opinion of the principal
investigator or his medical representative, affects the participant's ability to
understand and collaborate with the requirements of the study protocol

- Any alcohol or drug abuse in the last 12 months prior to inclusion in the study that
has caused medical, professional or family problems, as indicated by clinical history;

- History of severe allergic reaction or anaphylaxis to the vaccine or components of the
study vaccine;

- History of asplenia;

- Participation in another clinical trial with product administration under
investigation during the six months prior to its inclusion in the study or scheduled
participation in another clinical trial in the two years following inclusion;

- Previous participation in a COVID-19 vaccine evaluation study or previous exposure to
a COVID-19 vaccine;

- Use of immunosuppressive therapies six months prior to inclusion in the study or its
scheduled use within two years of inclusion. Immunosuppressive therapies will be
considered: antineoplastic chemotherapy, radiation therapy, immunosuppressants to
induce tolerance to transplants, among others.

- Have received an immunosuppressive dose of corticosteroids in the last three months
prior to inclusion in the study or scheduled administration of an immunosuppressive
dose of corticosteroids for the three months following inclusion in the study. The
dose of corticosteroids considered immunosuppressive is equivalent to prednisone at a
dose of 20 mg / day for adults, for more than a week. The continuous use of topical or
nasal corticosteroids is not considered immunosuppressive;

- Have received blood products (transfusions or immunoglobulins) in the last three
months before inclusion in the study, or scheduled administration of blood products or
immunoglobulin in the two years following inclusion in the study;

- Suspected or confirmed fever within 72 hours prior to vaccination or axillary
temperature greater than 37.8 ° C * on the day of vaccination (inclusion may be
postponed until the participant completes 72 hours without fever);

- Possible or confirmed case of COVID-19 on the day of vaccination (vaccination can be
postponed until the participant completes 72 hours without symptoms or the diagnosis
is ruled out);

- Have received vaccine with live attenuated virus in the last 28 days or inactivated
vaccine in the last 14 days prior to their inclusion in the study, or have
immunization scheduled for the first 28 days after their inclusion in the study;

- History of bleeding disorders (for example, deficiency of clotting factors,
coagulopathy, platelet dysfunction), or previous history of bleeding or significant
bruising after IM injection or venipuncture.

- Any other condition that, in the opinion of the principal investigator or his medical
representative, could jeopardize the safety or rights of a potential participant or
that would prevent him from complying with this protocol.