Phase I:
1) Solicited Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causation (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 3 days after dose.
2) Unsolicited Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 28 days after dose.
3) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times).
4) Neutralizing antibody titer: Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times).
5) % ACE2-RBD inhibition: Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times).
6) Molecular inhibition titer (mVNT50). Measurement time: Day 14 or 28 (random distribution of the study sample between the two times).
Phase II:
1) Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes, No), - Duration (Time from start date until end date of event), -Description of the event, Result (Recovered, Recovered with squeals, Persists, Death, Unknown), - Causality (Causal association consistent with vaccination, Undetermined, Inconsistent causal association with vaccination, not classifiable). Measurement time: daily for 28 days after each dose.
2) Solicited Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causation (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 3 days after dose.
3) Unsolicited Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious) , -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 28 days after dose.
4) Neutralizing antibody titer: Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times).
5) % ACE2-RBD inhibition: Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times).
6) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 14 or 28 (random distribution of the study sample between the two times).