COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Experimental Group: FINLAY-FR-2 + FINLAY-FR-1A.
FINLAY-FR-2: 25 µg of RBD-TT, by intramuscular route, 0.5 mL, in scheme 0 - 28 days.
FINLAY-FR-1A: 50 µg of d-RBD + Aluminum Hydroxide Gel, by intramu
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Injections, Intramuscular
Sponsors
Finlay Vaccine Institute (IFV)
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 3 and 18 years. 2. Voluntariness expressed through informed consent to participate in the study: - Subjects 3-11 years old: 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 3 and 9 years of age) or the Body Mass Index 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). Inclusion criteria to be considered for the evaluation of the duration of the response and the safety and immunogenicity of the booster dose: 1. Subjects included in the SOBERANA PEDIATRIA trial with a completed heterologous schedule and with immunological results at t70. 2. Voluntary consent expressed through informed consent to participate in the study for the new stages: a) Subjects aged 3-11 years: Informed Consent from parents or legal guardians b) Subjects aged 12-18 years: Informed Consent from parents or legal guardians and Informed Assent from the adolescent
Exclusion criteria
Exclusion criteria: 1. Subjects with acute febrile or infectious disease at the time of the vaccine application or in the 7 days prior to its administration. 2. Subjects that meet any of the following criteria: a) Previous or current history of SARS-CoV 2 infection. b) SARS-CoV 2 PCR positive. c) Be declared in the category of contact or suspect at the time of inclusion. 3. Subjects with a history of hypersensitivity to Thiomersal or any of the components of the formulations. 4. Subjects with a history of having been immunized with a SARS-CoV 2 vaccine. 5. Subjects with a history of having received a vaccine from the Cuban immunization scheme, in a period of less than 30 days prior to the administration of the product under investigation. 6. Use of any investigational product in the 30 days prior to immunization. 7. Application of vaccines containing tetanus toxoid in the last 3 months. 8. History of chronic diseases. 9. Subjects with a history of major congenital malformations (defects that have a significant functional compromise for the individual's life, have medical consequences and require early, sometimes urgent, care). 10. Primary or secondary immune system disease. 11. History of neoplastic disease. 12. History of severe allergic reactions. 13. Treatment with immunomodulators in the last 30 days (eg steroids (except topical and inhaled), Interferon, Immunoferon, Nasalferon, Transfer Factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Heberferon, Thymosin, Levamisole). 14. Subjects with a history of Convulsive Disease. 15. History of treatment with blood products such as blood cell, plasma, whole blood or platelet concentrate transfusions in the last 4 months. 16. Splenectomy or splenic dysfunction. 17. Child with a minor or mentally disabled mother or father. 18. Pregnancy or lactation (a pregnancy test will be carried out before inclusion and administration of each dose to all girls and adolescents who menstruate). 19. Subjects with tattoos in the deltoid region of both arms. 20. Subjects with a history or positive results for: antibodies against HIV1 + 2, antibodies against hepatitis C, surface antigen of the hepatitis B virus or VDRL serology. 21. History of psychoactive substance use in the last 6 months. Exclusion criteria to be considered for the evaluation of the duration of the response and the safety and immunogenicity of the booster dose: 1. Subject who has caused interruption in the SOBERANA PEDIATRIA study 2. Subjects with a history of having received any vaccine against SARS-CoV 2 in addition to the heterologous schedule applied in the clinical trial. 3. Subject with a positive SARS-CoV-2 antigen test at the time prior to the administration of the booster dose or convalescent (diagnosis made by PCR) 4. Subjects with febrile or acute infectious disease at the time of vaccine application or in the 7 days prior to its administration 5. Subjects with a history of having received any vaccine from the Cuban immunization schedule, in a period of less than 30 days prior to the administration of the booster dose 6. Use of any investigational product in the 30 days prior to the administration of the booster dose 7. Treatment with immunomodulators in the last 30 days (e.g. steroids (except topical and inhaled), Interferon, Immunoferon, Nasalferon, Transfer Factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Heberferon, Thymosin, Leva
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: 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. Phase II: Concentration of specific anti-RBD IgG antibodies. Measurement time: Day 0, 42, 70, period of time between 5 and 12 months after the completion of the heterologous regimen and 14 days after the booster dose | — |
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 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, 42 and 70. 4) Neutralizing antibody titer: Measurement time: Day 42, 70, period of time between 5 and 12 months after the completion of the heterologous regimen and 14 days after the booster dose. 5) % ACE2-RBD inhibition: Measurement time: Day 0, 42, 70, period of time between 5 and 12 months after the completion of the heterologous regimen and 14 days after the booster dose. 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, Undetermined, Inconsistent causal association with vaccination, not classifiable). Measurement time: daily for 28 days af | — |
Countries
Cuba
Contacts
Public ContactBeatriz Paredes Moreno
Finlay Vaccine Institute
Outcome results
None listed