COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Abdala - protein subunit COVID-19 vaccine (RBD 50 mcg + 0.30 mg aluminum hydroxide): 0.5 mL intramuscularly in the deltoid region (schedule 0-14-28 days).
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Injections, Intramuscular
Vaccine Abdala
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) Age between 3 and 18 years at the time of inclusion. 2) General physical examination and by appliances without alterations at the time of inclusion. 3) Nutritional assessment: weight / height ratio between 10 and 90 percentile (for children between 3 and 9 years of age). Body Mass Index (BMI) for the age between 10 and 90 percentile for adolescents between 10 and 18 years old, according to the cut-off points for the Cuban pediatric population. 4) Voluntariness of both parents (or legal guardian) by signing the informed consent, as well as informed consent for adolescents aged =12 years.
Exclusion criteria
Exclusion criteria: 1) History of SARS-CoV-2 infection or with this diagnosis at the time of inclusion in the study. 2) Contact or suspect of COVID-19 at the time of inclusion. 3) Body temperature = 37ºC at the time of vaccination (vaccination can be deferred up to 48 hours). 4) Acute infectious disease in the three days prior to the application of the vaccine. 5) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion. 6) History of having received a vaccine against SARS-CoV-2 or against other coronaviruses. 7) Have received any other vaccine, in the 14 days prior to the administration of each dose. 8) Administration of any research product in the last 30 days or that its use is planned during the clinical trial. 9) Having been treated in the last 30 days or with any medical condition that requires an immunomodulator (interferon, transfer factor, biomodulin T, thymosin, etc.), steroid (except topical or inhaled) or cytostatic during the study. 10) Have received blood, immunoglobulins or blood products in the three months prior to the start of the study. 11) Known hypersensitivity to thiomersal and to any of the components of the vaccine under study. 12) Tattoos in both deltoid regions that interfere with the injection site safety assessment. 13) History or suspicion of alcoholism or drug dependence. 14) Positive urine pregnancy test, before the administration of any of the three doses in women with biological capacity to have a pregnancy (history of menarche).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety - Adverse clinical events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Relation of causality (consistent with vaccination, indeterminate, inconsistent with vaccination, not classifiable), -Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Study exit, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: before the application of each dose of the vaccine and in the first hour after the inoculation of the product (in each dose), and on the 7th day after the first dose. 2) A non-inferiority immunobridging study to extrapolate the efficacy of the Abdala vaccine in paediatric ages of 3-18 years, from immunogenicity results based on the evaluation of neutralizing antibodies (NAb) against SARS-CoV-2. The design followed basic principles for this type of analyses according WHO guidelines. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Proportion of subjects with SARS-CoV-2 anti-RBD IgG antibodies seroconversion (seroconversion will be considered as that = 4 times the initial determination of the antibody titer). Measurement time: at 42 (+3 days) with respect to baseline time. 2) Inhibition to ACE2 (by ELISA - Enzyme-linked immunosorbent assay). Measurement time: at 42 (+3 days) with respect to baseline time. 3) SARS-CoV-2 viral neutralization response percentage (only 10% of those samples that have = 30% inhibition at a 1/100 dilution will be evaluated in the RBD-ACE-2 binding neutralization assay ). Measurement time: at 42 (+3 days) with respect to baseline time. | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed