immunosenescence
Conditions
Interventions
Group 1-Control: CIGB 2020 by nasal route (spray: 0.1 mL in each nostril, in 5 cycles with 5-minute intervals) at baseline (time 0), at 7 and 14 days, and by sublingual route, daily, for 14 days.
Grou
Immunotherapy, Active
Administration, Intranasal
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1- Age greater than or equal to 60 years, both sexes. 2- Personal history of HT, DM, cardiovascular diseases, kidney disease, cancer, osteoarthritis, atherosclerosis, obesity, chronic inflammatory disorders, autoimmune disorders, or any other that could constitute a risk factor for the competition of your innate immune system. 3- Expression levels of at least one of the Toll-like receptors: TLR3, TLR7 and TLR8, lower than the GUS control. 4- Voluntary nature of the patient to participate expressed through the delivery of signed informed consent.
Exclusion criteria
Exclusion criteria: 1- Expression levels of each of the Toll-like receptors (TLR3, TLR7 and TLR8), all above the GUS control. 2- Diagnosis of SARS-CoV-2 infection within 14 days prior to recruitment. 3- Acute illness at the time of recruitment, defined as the presence of a moderate or severe illness with or without fever. 4- Axillary temperature = 38.0 ° C. 5- History of tonsillectomy. 6- Use of immunosuppressive drugs or chemotherapy at some point during the month prior to recruitment. 7- Use of any investigational product (medicine or vaccine) within 30 days prior to recruitment, or that has been planned during the study period. 8- Liver cirrhosis, hepatocellular carcinoma or a history of liver transplantation. 9- History of allergy to any of the ingredients of the vaccine under study. 10- Any problem that makes proper patient monitoring impossible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Activation of markers of the innate immune system (levels of TLR3, TLR7, or TLR8): Measurement time: at baseline and, on day 15 (end of treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with increased expression of TLR3; TLR7; TLR8. Measurement time: at baseline and on days 8 and 15 post-treatment. 2. Clinical Adverse Events-AE (They will be measured as: -AE occurrence (Yes, No), -AE description (name of event), -AE intensity (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, definitive), -Measures taken (None, Administration of some pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization), -Result (Fully resolved, Resolved with sequelae, Conditions in improvement, Present condition and unchanged, worsening, death caused by this event)). Measurement time: daily throughout the follow-up of the subjects. | — |
Countries
Cuba
Contacts
Public ContactZurina Cinza Estevez
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed