COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Experimental Group 1: FINLAY-FR-2 25 µg RBD-TT, Intramuscular (IM), 0.5 mL, 0 – 28 days. Presentation: Vial with single dose.
Experimental Group 2: FINLAY-FR-2 25 µg RBD-TT, IM, 0.5 mL, 0 – 28 days
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. Subjects who give their informed consent to participate in the study in writing. 2. Subjects aged between 19 and 80 years. 3. Women of childbearing age who use contraceptive methods during the study and are willing to use them up to 3 months after the corresponding vaccination schedule has concluded.
Exclusion criteria
Exclusion criteria: 1. Subjects with acute febrile or infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application. 2. Subjects with diminished mental faculties for decision making. 3. Subjects with a history of hypersensitivity to thiomersal or to some of the components of the formulation. 4. Previous or current history of SARS-CoV-2 infection (questioning) 5. Application of vaccines containing tetanus toxoid in the last 3 months. 6. Subjects previously vaccinated against SARS-CoV-2. 7. Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, Biomodulin T, any gamma globulin, Levamisole, Heberferon, thymosin) or other drugs with immunomodulatory action. In addition, those people who, due to their underlying disease, require immunomodulatory treatment during the development of the study. 8. Pregnancy, puerperium or lactation. 9. Subjects with tattoos in the deltoid region on both arms. 10. Decompensated chronic diseases that limit vaccination according to clinical criteria. 11. HIV subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies. 12. Subjects with unstabilized malignant disease or who are receiving cytostatic treatment and / or radiotherapy during the time of the study or have been receiving it in the last three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virologically confirmed symptomatic infection of Covid-19. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Confirmed Covid-19 infection with signs of severe systemic disease. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. 2. Confirmed SARS-Cov-2 infection from routine surveillance or determinations of the presence of antigens. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. 3. Death from causes directly attributable to a complication of COVID-19 Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. 4. Virologically confirmed disease of Covid-19. Measurement time: starting 14 days after the candidate's first dose and up to 28 days. 5. Duration of the disease, measured from: Time to negativization and Duration of symptoms 6. Immunogenicity (IgG antibody concentration, Neutralizing antibody titre, determined by neutralization assay and ACE2-RBD interaction inhibition assay (% inhibition at 1/100 dilution; ID50). Measurement time: from 14 days after the candidate's first dose and until the end of the study (approximately 160 days) 7. Reactogenicity (Incidence of Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), 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), - Causal relationship (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: 3 days after each dose 8. 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 (Seriou | — |
Countries
Cuba
Contacts
Public ContactMayra Garcia Carmenate
Provincial Center of Hygiene and Epidemiology of Havana
Outcome results
None listed