COVID-19 COVID-19 SARS-CoV-2
Conditions
Interventions
Group I, Abdala (Experimental): 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 in the deltoid region.
Group II, Ma
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Single Dose
Injections, Intramuscular
Administration, Intranasal
ABDALA vaccine
MAMBISA vaccine
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Subjects previously vaccinated with the full schedule (three doses) of Abdala. 2) Minimum of 5 and a half months after receiving the 3rd dose of Abdala. 3) Voluntariness of the subject by signing the informed consent.
Exclusion criteria
Exclusion criteria: 1) History of SARS-CoV-2 infection or suspected COVID-19 at the time of inclusion. 2) Body temperature = 37ºC at the time of vaccination (vaccination can be deferred up to 48 hours). 3) Acute infectious disease in the three days prior to the application of the vaccine. 4) History of having received another vaccine against SARS-CoV-2 (different from Abdala). 5) Known hypersensitivity to thiomersal and to any of the components of the formulation under study. 6) Pregnancy or lactation referred by the volunteer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in geometric means of SARS-CoV-2 anti-RBD IgG antibody titers (numerical value). Measurement time: on days 0 and 14 (+ 3 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Anti-RBD IgG antibody titers of SARS-CoV-2 at the time of application of the corresponding booster dose (numerical value). Measurement time: At baseline. 2) Percentage of individuals with inhibition of the interaction of RBD with its ACE2 receptor = 30% in a subgroup of individuals (by ELISA - Assay by enzyme-linked immunosorbent). Measurement time: on days 0 and 14 (+ 3 days). 3) IgA antibody response in serum and nasal discharge in a patient’s subset (values according to sample type). Measurement time: on days 0 and 14 (+ 3 days). 4) Adverse clinical events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Relation of causality (unrelated, doubtful, possible, probable, definitive), -Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Study exit, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequels, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: At the next 30 minutes after the vaccine was applied and, after 14 days (with review of the ambulatory card of adverse events, in the possession of each participant). | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed