COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Group 1 (Experimental): CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg)
0.5 mL intramuscularly in the deltoid region (schedule 0-14-28 days).
Group 2 (Control): Placebo
0.5 mL intramuscularly in the deltoid region (schedule 0-14-28 days).
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Placebos
Injections, Intramuscular
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Individuals aged between 19 and 80 years 2) Physical examination without significant alterations. 3) Voluntariness of the subject by signing the informed consent.
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of SARS-CoV-2 infection confirmed by RT-PCR or with this virological diagnosis at the time of inclusion in the study. 2) Convalescent, contact or suspect of COVID-19 at the time of inclusion. 3) Subjects who have received a vaccine candidate against COVID-19. 4) Acute infection in the last 15 days or presence, at the time of inclusion in the study, of signs and symptoms such as: fever, cough, dyspnea or anosmia / ageusia. 5) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion. 6) Body mass index =18 or = 35 Kg / m2. 7) Subjects with tattoos in both deltoid regions. 8) Administration of any research product in the last three months. 9) Subject treated in the last three months 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 formulation under study. 12) History or suspicion of alcoholism or drug dependence. 13) Pregnancy or breastfeeding. Woman of reproductive age not using contraceptives or planning pregnancy. 14) Obvious mental incapacity to issue consent and act accordingly with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaccine efficacy (Number of symptomatic COVID-19 subjects with no evidence of previous exposure to viral infection): Those subjects with SARS-CoV-2 positive RT-PCR who present at least one major symptom or sign will pay tribute to the efficacy evaluation or at least two of the minor symptoms or signs of COVID-19. Measurement time: from 14 days after the 3rd dose of the research product. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Prevention of mild, moderate and severe forms of COVID-19 (number of symptomatic COVID-19 subjects according to intensity and evolution): Measurement time: from 14 days after the 3rd dose of the research product. 2) Prevention of asymptomatic cases in individuals confirmed by SARS-Co-V-2 PCR (number of SARS-CoV-2 PCR-positive subjects evolving asymptomatically). Measurement time: from 14 days after the 3rd dose of the research product. 3) 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), -Causality relationship (unrelated, doubtful, possible, probable, definitive), -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 sequels, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: before the administration of each dose of the research product, in the first hour after inoculation of the product (in each dose), and in the first 72 hours in active research in the community. 4) Proportion of subjects with seroconversion of SARS-CoV-2 anti-RBD IgG antibodies (seroconversion will be considered as that = 4 times the initial determination of the antibody titer). Measurement time: at 56 ± 5 days with respect to baseline time. 5) Specific anti-RBD IgG antibodies (geometric mean). Measurement time: at 56 ± 5 days with respect to baseline time. 6) Inhibition to ACE2 (by ELISA - Enzyme Linked Immunoadsorption Assay). Measurement time: at 56 ± 5 days with respect to baseline time. 7) SARS-CoV-2 viral neutralization response percentage (only those samples that have = 50% inhibition at a 1/100 dilution in the RBD-ACE-2 binding neutralization assay will be evaluated). Measurement time: at 56 ± 5 days with respect to baseline time. | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed