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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016500
Receipt No. 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 2017/02/11

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Basic information
Public title Safety and efficacy of live attenuated vaccine in patients received hematopoietic stem cell transplantation
Acronym FBMTG-VAC2015
Scientific Title Safety and efficacy of live attenuated vaccine in patients received hematopoietic stem cell transplantation
Scientific Title:Acronym FBMTG-VAC2015
Region
Japan

Condition
Condition Recipients of hematopoietic stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluated the safety and efficacy of live attenuated vaccine of measles, mumps, VZV and rubella virus in patients received HSCT
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Titers of antibody against measles, rubella, mumps and VZV in HSCT patients after vaacination
Key secondary outcomes Safety of live attenuated vaccine in HSCT patients

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 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.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiko kamimura
Organization Harasanshin General Hospital
Division name Department of Hematology
Zip code
Address 1-8 Taihaku-cho, Hakata-ku, Fukuoka 812-0033, Japan
TEL 092-291-3434
Email chk96670@hkg.odn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiko Kamimura
Organization Harasanshin General Hospital
Division name Department of Hematology
Zip code
Address 1-8 Taihaku-cho, Hakata-ku, Fukuoka 812-0033, Japan
TEL 092-291-3434
Homepage URL
Email chk96670@hkg.odn.ne.jp

Sponsor
Institute Fukkuoka Blood and Marrow Transplantation Group
Institute
Department

Funding Source
Organization Fukuoka Blood and Marrow Transplantation Group
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
Address
Tel
Email

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
2015 Year 02 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
2015 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 10 Day
Last modified on
2017 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.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


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