COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Vaccine candidate CIGB-66 (RBD 50 µg + Aluminum hydroxide 0,30 mg)/0,5 mL by intramuscular route, in the deltoid región, schedule 0-14-28 days.
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Injections, Intramuscular
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Not applicale
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects of both sexes. 2. Age between 19 and 80 years, extremes are included. 3. Subjects who grant their consent to participate.
Exclusion criteria
Exclusion criteria: 1. Individuals previously vaccinated with a vaccine candidate or SARS-CoV-2 vaccine. 2. Documented history of previous COVID-19 infection by medical questioning. 3. Allergy to any of the components of the vaccine. 4. Administration of immunosuppressants in the 30 days prior to vaccination 5. Decompensated chronic diseases that limit vaccination. 6. Pregnancy, puerperium and lactation. 7. Acute illness that contraindicates vaccination. 8. HIV positive subject with detectable viral load, opportunistic disease or CD4 + count less than 200 copies (according to the last follow-up check of the patient).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Virologically confirmed symptomatic infection of Covid-19 (Yes/No). Measurement time: from 14 days after the administration of the third dose of CIGB-66, for 4 months. 2. Confirmed Covid-19 infection with signs of severe systemic disease (Yes/No). Measurement time: from 14 days after the administration of the third dose of CIGB-66, for 4 months. 3. Confirmed SARS-Cov-2 infection from routine surveillance (Yes/No). Measurement time: from 14 days after the administration of the third dose of CIGB-66, for 4 months. 4. Death from causes directly attributable to a complication of COVID-19 (Yes No). Measurement time: from 14 days after the administration of the third dose of CIGB-66, for 4 months. 5. Global burden of incidence: Cumulative incidence of cases in the observation period. Measurement time: from 14 days after the administration of the third dose of CIGB-66, for 4 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Virologically confirmed COVID-19 disease. Measurement time: during vaccination intervals and up to 28 days after the third dose. 2. Confirmed COVID-19 disease evolving toward severity. Measurement time: during vaccination intervals and up to 28 days after the third dose of the vaccine candidate. 3. Confirmed COVID-19 disease evolving to Death from a cause directly attributable to a COVID-19 complication. Measurement time: during the vaccination intervals and up to 28 days after the third dose of the vaccine candidate. 4. Virologically confirmed asymptomatic SARS-Cov-2 infection detected during a surveillance action. Measurement time: during vaccination intervals and up to 28 days after the third dose of the vaccine candidate. 5. Proportion of subjects hospitalized for confirmed COVID-19 disease. Measurement time: from 14 days after the administration of the first dose of CIGB-66, and for 4 months. 6. Adverse Events-AE (Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Seriousness of adverse events (Serious, Not serious), -Causality relationship (causal association consistent with vaccination, Indeterminate, Inconsistent causal association with vaccination, not classifiable), - Result (Completely resolved, Resolved with sequelae, Conditions improving, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: 1 hour after the administration of each dose, 14 days after the administration of the 1st and the 2nd dose, respectively, and up to 28 days after the 3rd dose of the vaccine candidate. | — |
Countries
Cuba
Contacts
Public ContactSonia Resik Aguirre
Institute of Tropical Medicine "Pedro Kouri" (IPK)
Outcome results
None listed