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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035404
Receipt No. R000040341
Scientific Title Multcenter prospective cohort study of attenuated live vaccines in patients receiving steroid or immunosuppressive agents
Date of disclosure of the study information 2018/12/30
Last modified on 2019/06/30

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Basic information
Public title Multcenter prospective cohort study of attenuated live vaccines in patients receiving steroid or immunosuppressive agents
Acronym Multcenter study of attenuated live vaccines
Scientific Title Multcenter prospective cohort study of attenuated live vaccines in patients receiving steroid or immunosuppressive agents
Scientific Title:Acronym Multcenter study of attenuated live vaccines
Region
Japan

Condition
Condition Patients under steroid or immunosuppressive agents
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Nephrology Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy and safety of attenuated live vaccines in patients receiving steroid or immunosuppressive agents
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of seropositivity rates of measles, rubella, varicella and mumps after vaccination of MR vaccine, measles vaccine, rubella vaccine, varicella vaccine and mumps vaccine.
Key secondary outcomes 1) Comparison of antibodies between before and after vaccination of each virus.
2) Analysis of risk factors of vaccine failure.
3) Adverse events
4) Immunological analysis of cases who suffered from vaccine-strain infection after vaccination.

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 Prevention
Type of intervention
Vaccine
Interventions/Control_1 Immunization of 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 of one or more of steroid (PSL, mPSL) or immunosuppressants (Tac, CsA, MZR, AZP, MMF, EVR, MTX, 6-MP, sirolimus)
3. Negative or borderline antibody titer of one or more of the following viruses: measles, rubella, varicella, or mumps.
4. Immunological parameters are as follows
1) CD4 counts>500/mm3
2) PHA lymphocyte stimulatory test-stimulation index>101.6
3) Serum IgG level>300mg/dl
5. Patients who had the history of rituximab treatment should show CD+B cells of more than 1%.
6. Steroid treatment has to be under 1mg/kg/d or 2mg/kg/2d of PSL
7. Inactive primary disease.
Key exclusion criteria 1) Patients under biological agents.
2) Patients under active primary disease.
3) Patients who are considered inappropriate for immunization of live attenuated vaccines according to the attached documents.
4) Patients who do not agree the study entry.
5) Patients who are considered inappropriate for immunization according to the physician in charge.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Kamei
Organization National Center for Child Health and Development
Division name Nephrology and Rheumatology
Zip code 157-8535
Address 2-10-1, Okura, Setagaya-ku, Tokyo
TEL +81-3-5494-7128
Email kamei-k@ncchd.go.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Kamei
Organization National Center for Child Health and Development
Division name Nephrology and Rheumatology
Zip code 157-8535
Address 2-10-1, Okura, Setagaya-ku, Tokyo
TEL +81-3-5494-7128
Homepage URL
Email kamei-k@ncchd.go.jp

Sponsor
Institute Nephrology and Rheumatology, National Center for Child Health and Development
Institute
Department

Funding Source
Organization A grant from the National Center for Child Health and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) The Japan Foundation for Pediatric Research
The Terumo Foundation for Life Sciences and Arts

IRB Contact (For public release)
Organization Ethical committee of National Center for Child Health and Development
Address 2-10-1, Okura, Setagaya-ku, Tokyo
Tel +81334160181
Email none

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
2018 Year 12 Month 30 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
2018 Year 12 Month 04 Day
Date of IRB
2018 Year 12 Month 04 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2024 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 29 Day
Last modified on
2019 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040341

Research Plan
Registered date File name
2018/12/30 ①研究計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/12/30 ②-4抗体価・有害事象報告票.docx


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