COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Group 1 (experimental) FINLAY-FR-1: 50 µg RBD + 20 µg EMV / alumina
0.5 mL, Intramuscular (IM), 0-28 days + Booster dose day 56 FINLAY-FR-1A: 50 µg dRBD / alumina, 0.5 mL, Intramuscular (IM). Presentation: Vial with single dose.
Group 2 (experimental) FINLAY-FR-2: 25
0.5 mL, Intramuscular (IM), 0-28 days + Booster dose day 56 FINLAY-FR-1A: 50 µg dRBD / alumina, 0.5 mL, Intramuscular (IM). Presentation: Vial with single dose.
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 aged between 19 and 80 years. 2) Subjects who give their informed consent to participate in the study in writing. 3) Women of childbearing age who use contraceptive methods during the study and are willing to use them up to three months after the corresponding vaccination schedule has concluded.
Exclusion criteria
Exclusion criteria: 1) Subjects with acute febrile or infectious disease in the seven 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 known hypersensitivity to any of the components of the formulation. 4) Previous history of SARS-CoV-2 infection or subjects positive to the antigen test at the time of inclusion. 5) Subjects previously vaccinated against SARS-CoV-2. 6) Application of vaccines containing tetanus toxoid or the VA-MENGOC-BC vaccine in the last three months. 7) Application of any other vaccine of the extended immunization schedule in the last 30 days. 8) Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, HeberFERON, immunoferon, transfer factor, biomodulin T, any gamma globulin, levamisole, 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. 9) Subjects with tattoos in the deltoid region on both arms. 10) Decompensated chronic diseases that limit vaccination according to criteria clinical. 11) Subjects with unstabilized malignant disease or who are receiving oncospecific treatment (cytostatics and / or radiotherapy) during the time of the study or have been receiving it in the last three months. 12) HIV positive subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies. 13) Pregnancy, puerperium or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 42 and 70. Moreover, in a subset of subjects’ samples with seroconversion, the outcome will measure at months 4, 8 and 12 after completing scheme vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes, No), - Duration (Time from start date until end date of event), -Description of the event, Result (Recovered, Recovered with squeals, Persists, Death, Unknown), - Causality (Causal association consistent with vaccination, Undetermined, Inconsistent causal association with vaccination, not classifiable). Measurement time: daily for 28 days after each dose. 2) Solicited Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causation (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 3 days after each dose. 3) Unsolicited Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious) , -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 28 days after each dose. 4) % ACE2-RBD inhibition: Measurement time: Day 42 and 70 (It is measured on the total of subjects’ samples with seroconversion). 5) Molecular neutralization titer. Measurement time: Day 42 and 70 (It is measured on the total of subjects’ samples with seroconversion). 6) Neutralizing antibody titer: Measurement time Day 42 and 70 (It is measured on a subset of samples). | — |
Countries
Cuba
Contacts
Public ContactBeatriz Paredes Moreno
Finlay Vaccine Institute
Outcome results
None listed