Clinical Trial Info

SOBERANA 01

Authored by
Staff

This Phase 1/2 study will enroll male/female subjects 19-80 years of age.  

FINLAY-FR-1 intervention (Experimental): Dose 10 µg of RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.

FINLAY-FR-1 intervention (Experimental): Dose 20 µg of RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.

VA-MENGOC-BC® intervention (Control): Dose of 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.

Each intervention will consist of two age groups: 19-59 years and 60-80 years. The target sample size will consist of 40 volunteers.

Primary outcomes: 

1) Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes, No), - Duration (Time from the start date until the 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) Titer of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time At baseline and, 14, 28 and, 56 days.

Key secondary outcomes: 

1) Solicited Local and systemic Adverse Events measured as: -Occurrence of the Adverse Event (Yes, No), Duration (Time from start date until end date of event), -Intensity of the Adverse Event (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 7 days after each dose. 2) Unsolicited Adverse Events measured as: Description of the Adverse Event (name of the event), Duration (Time from start date until end date of event), -Intensity of the Adverse Event (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 each dose 3) Neutralizing antibody titer, measurement time: At baseline and, 56 days.