Frail patients over 60 years old
Conditions
Interventions
None listed
Sponsors
University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (60 years of age or older) scheduled for RSV vaccination who are attending or being hospitalized at the facility participating in this study will be included. (i) Patients who are 60 years of age or older at the time of obtaining consent. (ii) Patients who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding.
Exclusion criteria
Exclusion criteria: (i) Patients who have used immune checkpoint inhibitors in the past as treatment for malignant tumors (ii) Patients who are expected to have active infection at the time of vaccination (iii) Patients who have been treated with JAK inhibitors, anti-IL-6 antibodies, CTLA4 targeting agent, anti-IL-17A antibody, anti-IL-23p19 antibody, anti-IL-12/23p40 antibody (iv) Other subjects deemed inappropriate as research subjects by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in neutralizing antibody titer 1 month or 3 months post-vaccination depending on the presence or absence of flail | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Difference in IFN production capacity in lymphocytes 1 month or 3 months after vaccination depending on the presence or absence of frailty (2) Difference in cytokine production by lymphocytes 1 month or 3 months after vaccination in patients with or without flail 3) Difference in CD8+CD107a+ lymphocytes 1 month or 3 months after vaccination with or without flail 4) Difference in neutralizing antibody titer 1 month or 3 months after vaccination between frail and pre-frail 5) Difference in IFN production capacity in lymphocytes 1 month or 3 months after vaccination of frail and pre-frail 6) Difference in cytokine production capacity in lymphocytes 1 month or 3 months after vaccination between frail and pre-frail 7) Difference in CD8+CD107a+ lymphocytes 1 month or 3 months after vaccination in flail and pre-frail 8) Difference in neutralizing antibody titer before and after vaccination in the frail group 9) Difference in IFN production capacity of lymphocytes before and after vaccination in the frail group 10) Difference in cytokine production by lymphocytes before and after vaccination in the frail group 11) Difference in CD8+CD107a+ lymphocytes before and after vaccination in the frail group | — |
Countries
Japan
Contacts
Public ContactHironobu Tsubouchi
University of Miyazaki Faculty of Medicine
Outcome results
None listed