Clinical Trial of the COVID-19 Vaccine (Recombinant, Inactivated) in Brazil

Inclusion criteria

1. Adults aged between 18 and 59 years at the time of consent;

2. Agree to periodical contacts via phone, electronic means and home visits;

3. Good health conditions (absence of a clinically significant medical condition, acute
or chronic, determined by medical history, physical examination, and clinical
evaluation by the investigator);

4. Body Mass Index (BMI) of 17 to 40 kg/m² at the time of screening;

5. Intention of participating in the study by signing the Informed Consent Form;

6. A negative result for antibody testing against SARS-CoV-2 by CLIA performed within 7
days prior to study immunization;

7. No history of COVID-19 diagnosed by RT-PCR or antigen testing at screening visit and
therefore within 72 hours prior to study enrollment;

8. No history of vaccination against COVID-19.

Exclusion criteria

1. Use any product under investigation within 90 days prior to randomization or plan to
use a product during the period of participation in the study;

2. Have received vaccine in the last 28 days prior to inclusion in the study, or have
immunization scheduled throughout the study period;

3. Evidences of uncontrolled active 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;

4. Have a history of severe allergic reaction or anaphylaxis to the vaccine or study
vaccine components;

5. History of being allergic to chicken or eggs;

6. History of angioedema or anaphylactic reaction;

7. Have suspected or confirmed fever within 72 hours prior to vaccination or an axillary
temperature above 37.8°C* on the day of vaccination (inclusion may be delayed until
participant completes 72 hours without fever);

8. Altered vital signs, clinically relevant in the opinion of the principal investigator;

9. Neoplastic diseases (except basal cell carcinoma and cervical carcinoma in situ);

10. Suspected or confirmed diseases with compromised immune system including: congenital
or acquired immunodeficiencies and uncontrolled autoimmune diseases 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;

11. Make use of immunosuppressive therapies six months prior to inclusion in the study or
schedule use of immunosuppressants within two years of inclusion in the study. The
dose of corticosteroids considered immunosuppressive is the equivalent to prednisone
at a dose of 2,0 mg/kg/day for adults, for more than a week. The continuous use of
topical or nasal corticosteroids is not considered immunosuppressive. The following
therapies are considered immunosuppressive: antineoplastic drugs, radiotherapy,
immunosuppressants to induce tolerance to transplants, among others.

12. Have received blood products (transfusions or immunoglobulins) in the last three
months prior to inclusion in the study, or schedule administration of blood products
or immunoglobulins within two years of inclusion in the study.

13. Have a history of bleeding disorders (e.g., clotting factor deficiency, coagulopathy,
platelet dysfunction), or prior history of significant bleeding or bruising after IM
injection or venipuncture;

14. Have a history of 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
the clinical history;

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

16. The participant is a member of the team conducting the study or is in a dependent
relationship with one of the members of the team conducting the study. Dependent
relationships include close relatives (i.e., children, partner/spouse, siblings,
parents), as well as employees or students who are directly dependent on the
Researcher or local personnel conducting the study;

17. Any other condition that, in the opinion of the principal investigator or medical
representative, may jeopardize the safety or rights of a potential participant or
prevent them from complying with this protocol.

18. Abnormalities in screening laboratory tests considered to be exclusionary in the
opinion of the principal investigator or medical representative. Grade 1 alterations
are considered non-significant unless the principal investigator or medical
representative indicates otherwise. If any alteration in the tests is considered
temporary, the tests may be repeated in up to three opportunities during the screening
period;

19. Positive serological tests for the human immunodeficiency virus (ELISA anti-HIV1/2);
Hepatitis B (HbsAg or Anti-HBc) or Hepatitis C (total ELISA anti-HCV);

For females:

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

- The temperature measured with a temporal thermometer is considered equivalent to
the axillary temperature.