UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018627 |
|---|---|
| Receipt number | R000021555 |
| Scientific Title | The efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs: A prospective study |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2020/08/14 11:55:17 |
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Basic information
Public title
The efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs: A prospective study
Acronym
The prospective study of live attenuated vaccine for patients treated with steroids and immunosuppresive drugs
Scientific Title
The efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs: A prospective study
Scientific Title:Acronym
The prospective study of live attenuated vaccine for patients treated with steroids and immunosuppresive drugs
Region
| Japan |
Condition
Condition
collagen diseases, kidney diseases, digestive diaseases, liver diaseases, neurological diseases, kidney transplant patients
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of live attenuated vaccine in patients treated with steroid and immunosuppresive drugs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Assessment of antibody acquisition after vaccination classified by each virus.
2) Analysis of long maintenance of acquired immunity.
3) Analysis of incididence of adverse events.
Key secondary outcomes
1) Analysis of causes of vaccine failure.
2) Analysis of causes of adverse events.
3) Analysis of effect for prevention of virus infection.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
Live attenuated vaccine
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Equal or more than one years old.
2. Patients under treatment with immunosuppressants(tacrolimus, cyclosporine, mizoribine, azathioprine, methotrexate mycophenolate mofetil)
3. Normal cellular immunity (CD4 counts>500/mm3, PHA lymphocyte stimulatory test-stimulation index>101.6).
4. Serum IgG level>300mg/dl
5. Negative or borderline antibody titer of one or more of the following viruses: measles, rubella, varicella, or mumps.
6. Patients under treatment with prednisolone <1mg/kg/day or <2mg/kg every alternate day.
7. tacrolimus trough level<10ng/ml or cyclosporine trough level<100ng/ml.
8. Patients with low activity of underlying disease.
9. Patients who cannot discontinue immunosuppressants because of primary disease.
Key exclusion criteria
1. Steroid use of more than 1mg/kg/d.
2. For renal transplant recipients, <1 year since transplantation or acute rejection within the previous 6 months.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Nishimura |
Organization
Yokohama City University
Division name
Department of Pediatrics
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL
+81-45-787-2800
k_nsm@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Nishimura |
Organization
Yokohama City University
Division name
Department of Pediatrics
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL
+81-45-787-2671
Homepage URL
k_nsm@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Yokohama City University
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
Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
Tel
+81-45-787-2800
k_nsm@yokohama-cu.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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 10 | Day |
Last modified on
| 2020 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021555
