Immunosenescence in the elderly and their susceptibility to infectious diseases.
Conditions
Interventions
Inmuno-1: Injectable, intramuscularly. Contents 3 mg of Inmuno-1 in 3 mL of volume.
Inmuno-2: Injectable, intramuscularly. Contents 50 ug of Inmuno-2, in 3 mL of volume.
Group I (Experimental) –
Sponsors
Finlay Vaccine Institute (IFV)
National Center for Biopreparations (BioCen)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.- Female or male subject, age = 60 years. 2.- Written consent to participate in the study. 3.- Negative result to the rapid antibody test against COVID-19.
Exclusion criteria
Exclusion criteria: 1.- Subject with a history of acute infectious disease at the time of application of the research products or in the 7 days prior to the administration of the same 2.- Subject with a history of acute allergic processes or a history of severe allergic reactions. 3.- Subject with a history of chronic decompensation diseases 4.- Subjects with known hypersensitivity to any of the components of the research products 5.- Subjects with immunomodulatory treatment (immunostimulatory or immunosuppressive) 6.- Immunocompromised or immunosuppressed subjects (eg HIV, autoimmune disease) 7.- Subjects who received the research products three months before the start of the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lymphocytes T CD3+CD4+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment. Lymphocytes T CD3+CD8+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment. Lymphocytes B CD19+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment. NK cells CD3-CD56+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment. Monocyte cells CD14+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment. Dendritic cells CD11c+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Adverse Events-AE (They will be measured as: -AE Occurrence (Yes, No), -AE Description (name of the event), -Location: (local or systemic), Time of appearance: (Immediate, Delayed), Knowledge Previous: (Expected or not expected), AEs intensity (mild, moderate, severe), - Consequence (Serious, not serious), Causal relationship (very probable, probable, possible, improbable, unrelated, not evaluable/not classifiable), Outcome (recovered, not recovered, recovered with sequelae, death due to AD or unknown), - Attitude towards treatment (Continuation, definitive discontinuation)). Measurement time: up to 7 days after the end of the treatment | — |
Countries
Cuba
Contacts
Public ContactRinaldo Puga Gomez
Clinica Central Cira Garcia
Outcome results
None listed