UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052579 |
|---|---|
| Receipt number | R000058988 |
| Scientific Title | Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease |
| Date of disclosure of the study information | 2023/10/25 |
| Last modified on | 2023/10/31 17:19:09 |
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Basic information
Public title
Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease
Acronym
Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease
Scientific Title
Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease
Scientific Title:Acronym
Safety of Recombinant Zoster Vaccine in Patients with Inflammatory Bowel Disease
Region
| Japan |
Condition
Condition
Inflammatory bowel syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate vaccine-induced adverse events and relapses of enterocolitis in patients with inflammatory bowel disease who receive the herpes zoster vaccine (SHINGRIX).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of local and systemic adverse events
Key secondary outcomes
Effect of vaccination on primary disease of IBD
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Of those who have decided to receive the zoster vaccine, all cases that meet the following conditions are eligible.
1. Patients with inflammatory bowel disease (remission to moderate)
2. Adult
3. Regardless of gender
4. Outpatient at the time of vaccination (regardless of hospitalization or outpatient at the time of consent)
5. Patients who have given their voluntary consent to participate in this study
Key exclusion criteria
The following patients are excluded from the standpoint of ensuring safety.
1. All cases with liver disease, renal disease, heart disease, or other serious complications that are judged inappropriate by the attending physician
2. Cases with other autoimmune diseases
3. All cases of lactating women, pregnant women or those who may be pregnant
4. Patients who are judged to be unsuitable by other doctors
Among the above (1) research subjects, those who meet all (2) selection criteria and (3) none of the exclusion criteria are eligible.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoyoshi |
| Middle name | |
| Last name | Shibuya |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
0338133111
tomoyosi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyoshi |
| Middle name | |
| Last name | Shibuya |
Organization
Juntendo University
Division name
Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
0338133111
Homepage URL
tomoyosi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Tomoyoshi Shibuya
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University School of Medicine
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
Tel
0338133111
jcrtc_operation@juntendo.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
| 2023 | Year | 10 | Month | 25 | 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
| 2023 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation test
Management information
Registered date
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058988
