COVID-19
Conditions
Interventions
Group 1: They will be administered a single booster dose (0.5 mL, IM) of the SOBERANA®02 vaccine.
Group 2: They will be administered a single booster dose (0.5 mL, IM) of the SOBERANA® Plus vaccine.
COVID-19 Vaccines
Immunogenicity, Vaccine
Immunotherapy, Active
Single Dose
Injections, Intramuscular
Soberana 02,
Soberana Plus
Sponsors
Finlay Institute of Vaccines (IFV)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects of both sexes, over 18 years of age. 2. Subjects who give their informed consent to participate in the study. 3. Subjects who received the primary vaccination schedule against SARS-CoV-2 or convalescent subjects from COVID-19 in a period greater than or equal to 6 months.
Exclusion criteria
Exclusion criteria: 1. Subjects with febrile or acute infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application. 2. Subjects with chronic diseases NOT controlled, according to clinical criteria. 3. Subjects with a history of severe allergy (anaphylactic shock, angioneurotic edema, edema of the glottis, severe urticaria) to SOBERANA® 02 and SOBERANA® Plus vaccines. 4. Subjects convalescent from COVID-19 in a period of less than 6 months. 5. Having received a booster dose against SARS-CoV-2 in less than 6 months. 6. Application of another vaccine in the last 30 days. 7. Previous vaccination with tetanus toxoid vaccine in a period of less than 6 months. 8. History of having received a transfusion of blood or blood products in the last 3 months. 9. Women of childbearing age with a history of amenorrhea greater than 4 weeks or pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralizing antibody titers: Viral neutralization assay. Measurement time: 0, 28 days, 6 months and one year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1- Anti-RBD specific IgG antibody levels: UMELISA SARS-CoV-2 ANTI S for the quantification of IgG antibodies directed against the RBD protein of SARS-CoV-2. Measurement time: 0, 28 days, 6 months and one year. - Percentage of ACE2 inhibition: RBD:ACE2 interaction inhibition ELISA. Measurement time: 0, 28 days, 6 months and one year. 2 - Concentration of anti-TT IgG antibody: ELISA for determination of anti-TT IgG. Measurement time: 0 and one year. 3 - Determination of anti-RBD specific T cell populations: Assessment of the specific T response to the RBD by intracellular cytokine staining and multiparameter flow cytometry. Measurement time: 0, 28 days, 6 months and one year. 4 - Anti-SARS-CoV-2 N Protein IgG antibody concentration: quantitative indirect ELISA to determine anti-SARS-CoV-2 N Protein IgG antibody levels. Measurement time: 0, 28 days, 6 months and one year. 5 - Variables related to safety: Adverse Event (AE) Requested, Unsolicited. 6 - Requested AE (Any sign or symptom that appears after vaccination and up to 7 days after it is declared as requested AE). Description of the AE (Any sign or symptom that appears after vaccination and up to 7 days declared as requested AE), Duration of the AE (less than 24 hours, from 24 to 48 hours, more than 48 to 72 hours, more than 72 hours), AE Onset (less than 60 minutes, 60 minutes to 24 hours, more than 24 to 48 hours, more than 48 to 72 hours, more than 72 hours), AE Intensity (Mild, Moderate, Severe) , AE Severity (Serious, Non-severe), AE Outcome (Recovered, Recovered with sequelae, Persists, Death, Unknown), Causal relationship (Causal association consistent with vaccination, Undetermined, Causal association inconsistent with vaccination, Not classifiable ). Measuring time: 0, 28 days, 6 months and one year 7 - Unsolicited AE (Any sign or symptom that appears after vaccination and within 28 days, that is not within the AE requested.) Description of the AE (Any sign or symptom that appears after vaccination and u | — |
Countries
Cuba
Contacts
Public ContactLelyhana Verdecia Sanchez
Clinica1, La Lisa
Outcome results
None listed