COVID-19 COVID-19 SARS-CoV-2
Conditions
Interventions
Experimental Group SOBERANA PLUS: 50 µg of RBD + adjuvant, 0.5 mL by intramuscular route. Treatment scheme: one dose. Presentation: Vial with single dose.
Immunogenicity, Vaccine
Immunotherapy, Active
Injections, Intramuscular
Single Dose
Sponsors
Finlay Vaccine Institute (IFV)
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 2 and 18 years. 2. Voluntariness expressed through informed consent to participate in the study: - Subjects aged 2-11 years: Informed consent of parents or legal guardians. - Subjects aged 12-18 years: Informed Consent of the parents or legal guardians and Informed Assent of the adolescent. 3. Weight-height nutritional assessment between the 10th and 90th percentile (for subjects between 2 and 9 years of age) or the BMI between the 10th and 90th percentile for subjects between 10 and 18 years of age), according to the cut-off points for the Cuban pediatric population. 4. General, regional and apparatus physical examination without alterations. 5. Laboratory results within or outside the range of reference values ??but not clinically significant (For the subjects to be included in phase I). 6. Women of childbearing potential use safe contraceptive methods during the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of COVID-19 who meet any of the following criteria: a) Current history of infection or have received a medical discharge for SARS-CoV 2 in the two months prior to recruitment. b) History of critical clinical picture due to COVID-19, according to your medical history or obtained during the medical interview. 2. Subject with a history of having received any dose of vaccine candidates or vaccines against SARS - CoV - 2. 3. 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. 4. Subjects with antimicrobial treatment or sustained treatment with NSAIDs in the 7 days prior to the administration of the vaccine. 5. Subjects with chronic non-communicable diseases NOT controlled, according to clinical or laboratory criteria (bronchial asthma, chronic obstructive pulmonary disease, ischemic heart disease, arterial hypertension, diabetes mellitus, thyroid, neurological, hemolymphopoietic system diseases, liver failure, kidney failure , psychiatric illness at a psychotic level, among others). 6. Subjects with congenital or acquired immune system disease. 7. Subjects with a history of neoplastic disease. 8. Subjects with a history of substance abuse in the past 30 days or substance addictive illness, except smoking. 9. Subjects with diminished mental faculties. 10. Subjects with a history of severe allergic disease (anaphylactic shock, angioneurotic edema, glottis edema, severe urticaria). 11. Participation in another clinical trial of preventive or therapeutic intervention in the last 3 months. 12. Application of another vaccine in the last 30 days. 13. Treatment with immunomodulators in the last 30 days, eg; steroids (except for the occasional use of topical or inhaled steroids), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibodies, biomodulin T, any ganmaglobulin, levamisole, heberferon, thymosin) or those who, due to their underlying disease, require treatment immunomodulator, which may coincide during the development of the study. 14. History of having received a blood transfusion or blood products in the last 3 months. 15. Subjects with difficulties in attending the planned follow-up consultations. 16. Splenectomy or splenic dysfunction. 17. Pregnancy, puerperium or lactation. 18. Subjects with tattoos in the deltoid region of both arms. 19. Subjects with positive results to the determinations of HIV, Hepatitis B Surface Antigen, Hepatitis C Antibody and VDRL Serology. (For Phase I)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: 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: 28 days after dose. Phase II 1) Molecular inhibition titer (mVNT50). Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times). | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: 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 3 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 to pre-vaccination). Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times). 4) Neutralizing antibody titer: Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times). 5) % ACE2-RBD inhibition: Measurement time: At baseline and, 14 or 28 days (random distribution of the study sample between the two times). 6) Molecular inhibition titer (mVNT50). Measurement time: Day 14 or 28 (random distribution of the study sample between the two times). Phase II: 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, Un | — |
Countries
Cuba
Contacts
Public ContactBeatriz Paredes Moreno
Finlay Vaccine Institute
Outcome results
None listed