Chronic respiratory disease
Conditions
Interventions
None listed
Sponsors
University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (i) Patients who are 60 years of age or older at the time of obtaining consent (ii) Patients with chronic respiratory disease. (iii) Patients who have been fully informed about 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 with malignant tumors (ii) Patients who have used immune checkpoint inhibitors in the past (iii) Patients with active infection at the time of vaccination (iv) Patients vho have received JAK inhibitors, anti-TNFa antibodies, anti-IL-6 antibodies, CTLA4 targeting agent, anti-IL-17A antibody, anti-IL-23p19 antibody, anti-IL-12/23p40 antibody (V) Other subjects deemed inappropriate as research subjects by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in neutralizing antibody titer 1 month after vaccination with and without immunosuppressive treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Difference in neutralizing antibody titer 3 months after vaccination with and without immunosuppressive treatment 2) Difference in neutralizing antibody titer 6 months after vaccination with and without immunosuppressive treatment 3) Difference in neutralizing antibody titer 12 months after vaccination with and without immunosuppressive treatment 4) Difference in IFN production capacity in lymphocytes after vaccination with and without immunosuppressive treatment 5) Difference in neutralizing response to RSV after vaccination with and without immunosuppressive treatment 6) Differences in cytokine production in post-vaccine lymphocytes with and without immunosuppressive treatment 7) Positivity of RSV-PCR and number of fevers per year in subjects with family members of infants and school children 8) Number of fevers per year due to RSV infection after vaccination with and without immunosuppressive treatment 9) Differences in neutralizing antibody titer after vaccination with and without immunosuppressive treatment in patients with interstitial pneumonia (1 month, 3 months, 6 months, and 12 months) 10) Difference in neutralizing antibody titer after vaccination in bronchial asthma patients with and without immunosuppressive therapy or biological products (1 month, 3 months, 6 months, and 12 months) 11) Differences in neutralizing antibody titer or lymphocyte cytokine/IFN production capacity after vaccination in subjects who were introduced to immunosuppressive treatment during the course of the study and those who were not treated or treated with immunosuppressive treatment (6 months, 12 months) | — |
Countries
Japan
Contacts
Public ContactHironobu Tsubouchi
University of Miyazaki Faculty of Medicine
Outcome results
None listed