UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057303 |
|---|---|
| Receipt number | R000065504 |
| Scientific Title | Investigation of the effect of immunosuppressive treatment on the immunogenicity of RS virus vaccine. |
| Date of disclosure of the study information | 2025/03/16 |
| Last modified on | 2026/04/07 14:05:41 |
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Basic information
Public title
Investigation of the effect of immunosuppressive treatment on the immunogenicity of RS virus vaccine.
Acronym
Investigation of the effect of immunosuppressive treatment on the immunogenicity of RS virus vaccine.
Scientific Title
Investigation of the effect of immunosuppressive treatment on the immunogenicity of RS virus vaccine.
Scientific Title:Acronym
ITI-RSV
Region
| Japan |
Condition
Condition
Chronic respiratory disease
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is an observational study to determine whether the use of immunosuppressive agents affects the immunogenicity of the vaccine in adults 60 years of age or older with respiratory disease.Clinical information, saliva samples, and blood samples will be collected from adults 60 years of age or older with respiratory disease who have received RSV vaccine. Lymphocyte IFN production capacity, RSV neutralizing response, and anti-RSV antibody titers will be compared with and without the use of steroids or immunosuppressive drugs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in neutralizing antibody titer 1 month after vaccination with and without immunosuppressive treatment
Key secondary outcomes
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)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Tsubouchi |
Organization
University of Miyazaki
Division name
Faculty of Medicine
Zip code
8891692
Address
Kihara 5200, Kiyotake, Miyazaki
TEL
+81-985-85-7284
hironobu_tsubouchi@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Tsubouchi |
Organization
University of Miyazaki
Division name
Faculty of Medicine
Zip code
889-1692
Address
Kihara 5200, Kiyotake, Miyazaki
TEL
+81-985-85-7284
Homepage URL
hironobu_tsubouchi@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki Hospital Clinical Research Support Center
Address
Kihara 5200, Kiyotake, Miyazaki
Tel
0985-85-9403
rinken@med.miyazaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observational study, Patients aged 60 years or older with chronic respiratory disease attending the Department of Respiratory Medicine, Miyazaki University Hospital will be included.
Management information
Registered date
| 2025 | Year | 03 | Month | 16 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065504
