COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Experimental Group: FINLAY-FR-2 25 µg RBD-TT, Intramuscular route (IM), 0.5 mL, 0 – 28 days + FINLAY-FR-1A (50 µg d-RBD+ alumina, IM, 0.5 mL) as booster dose 56 day.
FINLAY-FR-2 Presentation: Vial wi
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Injections, Intramuscular
Sponsors
Finlay Vaccine Institute (IFV)
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Both sexes. 2. Age between 19 and 80 years, extremes are included. 3. Subjects who grant their consent to participate
Exclusion criteria
Exclusion criteria: 1. Individuals previously vaccinated with a vaccine candidate or SARS-CoV-2 vaccine. 2. Documented history of previous COVID-19 infection as a result of medical questioning. 3. Allergy to any of the components of the vaccine. 4. Administration of immunomodulators in the 30 days prior to vaccination. 5. Decompensated chronic diseases that limit vaccination. 6. Pregnancy, childbirth and the puerperium. 7. Acute illness that contraindicates vaccination 8. HIV subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies. 9. For the application of the booster dose, subject with a history of being convalescent of COVID, or having less than 5 months of the last dose applied.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Virologically confirmed symptomatic infection of Covid-19. Measurement time: from 14 days after the candidate's last dose. 2. Confirmed Covid-19 infection with signs of severe systemic disease. Measurement time: from 14 days after the candidate's last dose. 3. Confirmed SARS-Cov-2 infection from routine surveillance or determinations of the presence of antigens. Measurement time: from 14 days after the candidate's last dose. 4. Death from causes directly attributable to a complication of COVID-19. Measurement time: from 14 days after the candidate's last dose. 5. Case Cumulative incidence: Measurement time: from 14 days after the candidate's last dose. 6. Evaluate the immunogenicity of a dose of the vaccine candidate, in convalescent patients from COVID-19 with mild and moderate clinical symptoms and asymptomatic PCR positive. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Virologically confirmed disease of Covid-19. Measurement time: starting 14 days after the candidate's first dose and up to 28 days. 2. Confirmed Covid-19 infection with signs of severe systemic disease. Measurement time: starting 14 days after the candidate's first dose and up to 28 days. 3. Confirmed SARS-Cov-2 infection from routine surveillance or determinations of the presence of antigens. Measurement time: starting 14 days after the candidate's first dose and up to 28 days. 4. Death from causes directly attributable to a complication of COVID-19. Measurement time: starting 14 days after the candidate's first dose and up to 28 days. 5. Safety Incidence of Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from onset date until end date of event), Time of onset (Time from the previous dose to the onset of AE), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality relationship (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: 28 days after each dose. 6. Proportion of hospitalized subjects. Measurement time: from 14 days after the candidate's first dose. 8. Evaluate the duration of the immune response in primed subjects. 9. Evaluate the capacity to reinforce the immune response of SOBERANA 01 and SOBERANA Plus, after administration of the planned heterologous scheme, between 5-6 months after the last dose. 10. Evaluate the duration of the immune response induced by both booster doses for a minimum period of 6 months. | — |
Countries
Cuba
Contacts
Public ContactMayra Garcia Carmenate
Provincial Center of Hygiene and Epidemiology of Havana
Outcome results
None listed