COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Group 1: CIGB-66 (RBD 25 mcg + aluminum hydroxide 0.30 mg)
0.5 mL intramuscularly in the deltoid region (0-14-28 days schedule).
Group 2: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg)
0.5 mL intramuscularly in the deltoid region (0-14-28 days schedule).
Group 3: Placebo
0.5 mL intramuscularly in the deltoid region (0-14-28 days schedule).
Group 4: CIGB-66 (RBD 25 mcg + aluminum hydroxide 0.30 mg)
0.5 mL intramuscularly in the deltoid region (schedule 0-28-56 days).
Group 5: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg)
0.5 mL intramuscularly in the deltoid region (schedule 0-28-56 days).
Group 6: Placebo
0.5 mL intramuscularly in the deltoid region (schedule 0-28-56 days).
These interventions will be carried out during the first stage (phase I). Subsequently, an intermediate analysis will be carried o
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 54 Years
Inclusion criteria
Inclusion criteria: 1) Individuals aged between 19 and 54 years, both inclusive (for phase I) and between 19 and 80 years old, both inclusive (for phase II). 2) Physical examination without significant alterations. 3) Hematological and blood chemistry determinations within or outside normal ranges, without clinical relevance (only for phase I). 4) Voluntariness of the subject by signing the informed consent.
Exclusion criteria
Exclusion criteria: 1) Virological diagnosis by RT-PCR of infection to SARS-CoV-2. 2) Contact or suspect of COVID-19 at the time of inclusion. 3) Subjects at high risk of exposure to SARS-CoV-2 infection (contacts of confirmed cases, health workers in the 1st line of medical care [Emergency, ICU, other risk areas]). 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 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 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 |
|---|---|
| 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), -Causality relationship (no related, 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 sequelae, 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), at 24, 48 and 72 hours, and on the 7th day. 2. Proportion of subjects with seroconversion of anti-RBD IgG antibodies to SARS-CoV-2 (seroconversion will be considered as that = 4 times the initial determination of the antibody titer). Measurement time: on days 28 and 42 (for the short scheme 0-14-28) and 28, 56 and 70 (for the long scheme 0-28-56), with respect to the baseline time. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Specific anti-RBD IgG antibodies (geometric mean). Measurement time: on days 0, 28 and 42 (for the short vaccination schedule: 0-14-28) and 0, 28, 56 and 70 (for the long schedule: 0-28-56). 2. ACE2 inhibition (by ELISA - Enzyme-linked immunoadsorption assay). Measurement time: on days 0, 28 and 42 (for the short vaccination scheme) and 0, 28, 56 and 70 (for the long scheme). 3. Humoral response of specific anti-RBD IgM antibodies. Measurement time: on days 0, 28 and 42 (for the short vaccination scheme) and 0, 28, 56 and 70 (for the long scheme). | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed