Unique ID issued by UMIN | UMIN000016500 |
---|---|
Receipt number | R000019152 |
Scientific Title | Safety and efficacy of live attenuated vaccine in patients received hematopoietic stem cell transplantation |
Date of disclosure of the study information | 2015/02/25 |
Last modified on | 2021/02/14 14:56:13 |
Safety and efficacy of live attenuated vaccine in patients received hematopoietic stem cell transplantation
FBMTG-VAC2015
Safety and efficacy of live attenuated vaccine in patients received hematopoietic stem cell transplantation
FBMTG-VAC2015
Japan |
Recipients of hematopoietic stem cell transplantation
Hematology and clinical oncology |
Malignancy
NO
We evaluated the safety and efficacy of live attenuated vaccine of measles, mumps, VZV and rubella virus in patients received HSCT
Safety,Efficacy
Titers of antibody against measles, rubella, mumps and VZV in HSCT patients after vaacination
Safety of live attenuated vaccine in HSCT patients
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Vaccine |
We measure titer of antibody against measles, mumps, rubella and VZV before vaccination. Administer live attenuated vaccine if patient's titer of antibody against virus is not positive. Second dose is administered at 4 - 12 weeks after first dose. Finally we measure titer of antibody of virus that vaccine was administered 8 - 16 weeks after second dose.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1. Patients undergoing HSCT.
2. Twenty four months have been passed after HSCT.
3. No active chronic GVHD.
4. No immunosuppressive drugs such as tacrolimus, cyclosporine and prednisolone.
5. Three months have been passed after transfusion and six months after IVIG.
6. Patient's value go IVIG is equal or greater than 500 mg/dl.
7. Voluntary written informed consent.
1. Patient who received immunosuppressive medications.
2. History of malignant tumors.
3. Severe uncontrolled psychiatric disorder or illness.
4. Serious concurrent uncontrolled medical disorders (hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction, diabetes, hypertension and infectious diseases).
5. Pregnant or lactating female.
6. Unwillingness or inability to follow the procedures required in the protocol.
300
1st name | |
Middle name | |
Last name | Tomohiko kamimura |
Harasanshin General Hospital
Department of Hematology
1-8 Taihaku-cho, Hakata-ku, Fukuoka 812-0033, Japan
092-291-3434
chk96670@hkg.odn.ne.jp
1st name | |
Middle name | |
Last name | Tomohiko Kamimura |
Harasanshin General Hospital
Department of Hematology
1-8 Taihaku-cho, Hakata-ku, Fukuoka 812-0033, Japan
092-291-3434
chk96670@hkg.odn.ne.jp
Fukkuoka Blood and Marrow Transplantation Group
Fukuoka Blood and Marrow Transplantation Group
Self funding
NO
2015 | Year | 02 | Month | 25 | Day |
Unpublished
Completed
2015 | Year | 02 | Month | 16 | Day |
2015 | Year | 02 | Month | 20 | Day |
2015 | Year | 02 | Month | 25 | Day |
2018 | Year | 02 | Month | 28 | Day |
2015 | Year | 02 | Month | 10 | Day |
2021 | Year | 02 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019152
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |