COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Stage IIa:
Group 1- FINLAY-FR-2 (Experimental): high dose RBD conjugated to TT (batch 1) + adjuvant
0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Booster dose 56 days: 25 subjects with FINLAY-FR-2 (Experimental batch 1): high dose of conjugated RBD+adjuvant
0,5 mL, intramuscular (IM) and 25 subjects with FINLAY-FR-1A 50 ug dRBD/alumina, 0,5 mL,intramuscular (IM) Presentation: Vial with single dose.
Group 2- FINLAY-FR-2 (Experimental): high dose RBD conju
0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Booster dose 56 days: 25 subjects with FINLAY-FR-2 (Experimental batch 2): high dose of conjugated RBD+adjuvant
0,5 mL, intramuscular (IM) and 25 subjects with FINLAY-FR-1A 50 ug dRBD/alumina, 0,5 mL,intramuscular (IM) Presentation: Vial with single dose.
Stage IIb:
Group 1- FINLAY-FR-2 (Experimental): high
0.5 mL,by intramuscular route. Treatment scheme: 0-28 days. Booster dose 56 days: FINLAY-FR-1A 50 ug dRBD/alumina, 0,5 mL,intramuscular (IM) Presentation: Vial with single dose.
Group 2- FINLAY-FR-
0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Booster dose 56 days: FINLAY-FR-1A 50 ug dRBD/alumina, 0,5 mL,intramuscular (IM) Presentation: Vial with single dose.
Group 3 Placebo (cont
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Injections, Intramuscular
Placebos
FINLAY-FR-2
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 using contraceptive methods during the study. 4. General, regional and apparatus physical examination: normal or without clinically significant alterations. 5. Laboratory results within or outside the range of reference values ??but not clinically significant (for stage IIa)
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 antimicrobial treatment in the 7 days prior to the administration of the vaccine. 3. Subjects with Poor Weight (BMI <18.5) and Obesity (BMI = 34.9). 4. Subjects with non-communicable chronic diseases not controlled according to clinical or laboratory criteria (eg bronchial asthma, chronic obstructive pulmonary disease, diabetes mellitus, thyroid diseases, ischemic heart disease, arterial hypertension, psychiatric disease at the psychotic, neurological, system level hemolymphopoietic). 5. Subjects with congenital or acquired immune system disease. 6. Subjects with a history of unresolved neoplastic disease. 7. Subjects with a personal history of liver or kidney failure. 8. Subjects with a history of substance abuse during the last 30 days or addictive illness to toxic substances, except if the subject is in abstinence, in the case of alcoholics, and smoking. 9. Subjects with diminished mental faculties for decision making. 10. Subjects with a history of severe allergic disease (anaphylactic shock, angioneurotic edema, glottis edema, severe urticaria). 11. Subjects with a history of hypersensitivity to thiomersal or to some of the components of the formulation. 12. Subjects with a history of SARS and COVID-19 who meet any of the following criteria: a) Previous or current history of SARS-CoV-2 infection. b) Be declared in the category of contact or suspect at the time of inclusion. c) Subject with positive test for Anti-SARS-CoV-2 Antibodies. d) Subject with positive PCR at the time of inclusion. 13. Participation in another clinical trial in the last 3 months. 14. Application of vaccines containing tetanus toxoid in the last 3 months. 15. Application of other vaccines in the last 30 days. 16. Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Levamisole, Heberferon, thymosin) or other drugs with action immunomodulatory. In addition, those people who, due to their underlying disease, require immunomodulatory treatment during the development of the study. 17. Transfusion of blood or blood products in the last 3 months. 18. Subjects with difficulties in attending the planned follow-up consultations. 19. Splenectomy or splenic dysfunction. 20. Pregnancy, puerperium or lactation. 21. Subjects with tattoos in the deltoid region on both arms. 22. Subjects with positive results for HIV, Hepatitis B Surface Antigen, Hepatitis C Antibody and VDRL Serology. (For stage IIa). 23. Women with a positive pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage IIa: 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. Stage IIb: Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 14, 42, 56, 70, 84. | — |
Secondary
| Measure | Time frame |
|---|---|
| Stage IIa: 1) 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 7 days after each dose. 2) 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 . 3) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4-fold to pre-vaccination). Measurement time: Day 0, 14, 42, 56, 70, 84. 4) Neutralizing antibody titer: Measurement time: Day 0 (only IgG positive), 56, 70, 84 (Sample subset). 5) % ACE2-RBD inhibition: Measurement time: Day 0 (only IgG positive), 14, 42, 56, 70, 84. Stage IIb: 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 | — |
Countries
Cuba
Contacts
Public ContactBeatriz Paredes Moreno
Finlay Vaccine Institute
Outcome results
None listed