Evaluation of the synergistic effect of sequential administration of two immunostimulant products: Immuno-1 and Immuno-2 for the stimulation of the immune response in older adults. Exploratory study
- Conditions
- Immunosenescence in the elderly and their susceptibility to infectious diseases.
- Registration Number
- RPCEC00000315
- Lead Sponsor
- Finlay Vaccine Institute (IFV)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ymphocytes T CD3+CD4+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment.<br>Lymphocytes T CD3+CD8+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment.<br>Lymphocytes B CD19+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment.<br>NK cells CD3-CD56+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment.<br>Monocyte cells CD14+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment.<br>Dendritic cells CD11c+ (% of cells by flow cytometry). Measurement time: at baseline and, 7 days after end of treatment.
- Secondary Outcome Measures
Name Time Method 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