COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
SOBERANA Plus ST: 50 µg of d-RBD + adjuvant, 0.5 mL by intramuscular route. Treatment scheme: one dose. Presentation: Vial with single dose.
The vaccine will be applied to two groups of italian patien
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccines
Injections, Intramuscular
Single Dose
Sponsors
Finlay Vaccine Institute (IFV)
Eligibility
Sex/Gender
All
Age
19 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. The participant understands and agrees to comply with the study procedures and provides written informed consent. 2. Adults, 19 to 59 years of age, at time of consent. 3. Subjects with BMI of 18.5 to 34.9 kg/m2.
Exclusion criteria
Exclusion criteria: 1. A) COVID-19 convalescent group: a) A history of SARS-CoV-2 infection at time of recruitment or medical discharge for COVID-19 during the two months before recruitment; b) History of severe or asymptomatic COVID-19. B) Group of healthy individuals immunized with another vaccine: History of COVID-19. 2. Acute illness, febrile, 7 days prior to administration of investigational product or at screening. 3. Current use of any prescription of non-steroidal anti-inflammatory drugs (NSAIDs) or antimicrobial medications within 7 days prior to vaccination. 4. Any chronic medical disease or condition that, in the opinion of the clinical investigator, precludes study participation (e.g., subjects with respiratory disease (e.g., chronic obstructive pulmonary disease, asthma), diabetes mellitus, thyroid disease, cardiovascular disease (e.g., congestive heart failure, hypertension, and ischemic heart disease), liver and kidney chronic diseases, neurological conditions or bleeding disorder, psychiatric condition, etc.). 5. Any primary or secondary immunodeficiency. 6. Ongoing malignancy or recent diagnosis of malignancy. 7. A history of alcohol abuse or other recreational drug use within 30 days before the first vaccine administration, except smoking. 8. Demonstrated inability to comply with the study procedures (Mental problems or disorders). 9. A history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticarial, angioedema,). 10. A history of hypersensitivity to some vaccine component. 11. Participated in another investigational study involving any investigational product within 3 month prior to the day of enrollment. 12. A) COVID-19 convalescent group: a) Subjects vaccinated with any vaccine against SARS-CoV-2. B) Group of healthy individuals previously immunized with another vaccine: Subjects are excluded if they were not vaccinated between 3 and 12 months before recruitment. 13. Received any vaccine within 30 days prior to the day of enrollment. 14. Received systemic immunosuppressant or immune-modifying drugs, including cytostatic drugs and steroids. 15. History of transfusion of blood or blood products in the last 3 months. 16. Difficulties to comply with the schedule of clinical visit or to continue follow up clinical visits. 17. Splenectomy or splenic dysfunction. 18. Women of childbearing potential not using safe contraceptive methods during the study 19. Pregnancy, puerperium, or breastfeeding. 20. Any abnormality or permanent body art (e.g., tattoo) that would interfere with the observation of local reactions at the injection site (both deltoid region).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 dose. 3) Concentration of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time: Prevaccination and day 28 after vaccination. 4) % ACE2-RBD inhibition and Half-maximal molecular virus neutralization titer (mVNT50). Measurement time: Prevaccination, and day 28 after vaccination. 5) Viral Neutralization antibody titers against variants of concerns: Measurement time: Prevaccination and day 28 after vaccination. | — |
Countries
Cuba
Contacts
Public ContactYanet Climent Ruiz
Finlay Vaccine Institute
Outcome results
None listed