COVID-19
Conditions
Interventions
Abdala group (Experimental): All subjects included will receive the Abdala vaccine (RBD 50 µg + aluminum hydroxide 0.30 mg). It will be administered in a single dose by the intramuscular route: 0.5 mL
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
19 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Individuals between the ages of 19 and 60. 2) Subjects who have received: a) primary vaccination and booster with Abdala or b) primary vaccination with Soberana (02/plus) and booster dose (with Soberana or Abdala). 3) At least 8 months after receiving the last booster of the anti-COVID-19 vaccine. 4) Voluntary nature of the subject by signing the informed consent.
Exclusion criteria
Exclusion criteria: 1) Acute infectious disease in the three days prior to vaccine administration. 2) Uncontrolled chronic disease at the time of inclusion. 3) Known hypersensitivity to thiomersal and any of the components of the formulation under study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean difference of SARS-CoV-2 anti-RBD IgG antibody titers (numerical value). Time of measurement: on days 0 and 21 (±2 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) SARS-CoV-2 anti-RBD IgG antibody titers at the time of booster dose administration (numerical value). Time of measurement: at baseline. 2) Percentage of individuals with inhibition of the interaction of the RBD with its ACE2 receptor = 30% (by ELISA - Enzyme-linked immunosorbent assay). Time of measurement: on days 0 and 21 (±2 days). 3) Percentage and magnitude of viral neutralization response (Abdala neutralization capacity against different SARS-CoV-2 variants (KP.2, KP.3, BA.2.86, EG.5, JN.1, delta) in a subset of individuals. Measurement time: on days 0 and 21 (±2 days). 4) Clinical Adverse Events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of the AE (name of the event), -Intensity of the AE (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, definitive), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit from the study, Hospitalization / prolongation of hospitalization), -Outcome (Completely resolved, Resolved with sequelae, Conditions improving, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: within 20 minutes of vaccination and 21 days later (with review of the outpatient adverse event card, held by each participant). | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed