Unique ID issued by UMIN | UMIN000035404 |
---|---|
Receipt number | 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 | 2021/01/04 20:54:33 |
Multcenter prospective cohort study of attenuated live vaccines in patients receiving steroid or immunosuppressive agents
Multcenter study of attenuated live vaccines
Multcenter prospective cohort study of attenuated live vaccines in patients receiving steroid or immunosuppressive agents
Multcenter study of attenuated live vaccines
Japan |
Patients under steroid or immunosuppressive agents
Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Nephrology | Clinical immunology | Infectious disease |
Pediatrics |
Others
NO
Evaluation of the efficacy and safety of attenuated live vaccines in patients receiving steroid or immunosuppressive agents
Safety,Efficacy
Analysis of seropositivity rates of measles, rubella, varicella and mumps after vaccination of MR vaccine, measles vaccine, rubella vaccine, varicella vaccine and mumps vaccine.
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Vaccine |
Immunization of live attenuated vaccine
1 | years-old | <= |
Not applicable |
Male and Female
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.
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.
2000
1st name | Koichi |
Middle name | |
Last name | Kamei |
National Center for Child Health and Development
Nephrology and Rheumatology
157-8535
2-10-1, Okura, Setagaya-ku, Tokyo
+81-3-5494-7128
kamei-k@ncchd.go.jp
1st name | Koichi |
Middle name | |
Last name | Kamei |
National Center for Child Health and Development
Nephrology and Rheumatology
157-8535
2-10-1, Okura, Setagaya-ku, Tokyo
+81-3-5494-7128
kamei-k@ncchd.go.jp
Nephrology and Rheumatology, National Center for Child Health and Development
A grant from the National Center for Child Health and Development
Other
The Japan Foundation for Pediatric Research
The Terumo Foundation for Life Sciences and Arts
Ethical committee of National Center for Child Health and Development
2-10-1, Okura, Setagaya-ku, Tokyo
+81334160181
rinri@ncchd.go.jp
NO
2018 | Year | 12 | Month | 30 | Day |
Unpublished
Open public recruiting
2018 | Year | 12 | Month | 04 | Day |
2018 | Year | 12 | Month | 04 | Day |
2019 | Year | 03 | Month | 01 | Day |
2024 | Year | 02 | Month | 28 | Day |
2018 | Year | 12 | Month | 29 | Day |
2021 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040341
Research Plan | |
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Registered date | File name |
2023/01/01 | ①研究計画書4.0版.docx |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |
2018/12/30 | ②-4抗体価・有害事象報告票.docx |