UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057304 |
|---|---|
| Receipt number | R000065506 |
| Scientific Title | Investigation of the effect of flail on the immunogenicity of RS virus vaccine. |
| Date of disclosure of the study information | 2025/03/16 |
| Last modified on | 2025/03/16 19:11:34 |
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Basic information
Public title
Investigation of the effect of flail on the immunogenicity of RS virus vaccine.
Acronym
EFI-RSV
Scientific Title
Investigation of the effect of flail on the immunogenicity of RS virus vaccine.
Scientific Title:Acronym
EFI-RSV
Region
| Japan |
Condition
Condition
Frail patients over 60 years old
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is an observational study to determine whether the presence or absence of flail affects the immunogenicity of the vaccine in RSV vaccinees aged 60 years or older. clinical information, saliva samples, and blood samples will be collected at the time of RSV vaccination, 1 month after vaccination, and 3 months after vaccination. The IFN production capacity of lymphocytes, RSV neutralizing response, and anti-RSV antibody titer will be compared in the presence and absence of flail.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in neutralizing antibody titer 1 month or 3 months post-vaccination depending on the presence or absence of flail
Key secondary outcomes
(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
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
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.
Key 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.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Kitamura |
Organization
University of Miyazaki
Division name
Faculty of Medicine
Zip code
8891692
Address
Kihara 5200, Kiyotake, Miyazaki
TEL
0985857284
akiko_kitamura@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
0985859403
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study, to examine whether there is a difference in immunogenicity between patients with and without frailty, who are scheduled to be vaccinated against RSV (aged 60 years or older) while attending or hospitalized at the facilities participating in the study.
Joint Research Organization: Fujiki Medical and Surgical Clinic.
Management information
Registered date
| 2025 | Year | 03 | Month | 16 | Day |
Last modified on
| 2025 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065506
