UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2015 Year 02 Month 16 Day
Date of IRB	2015 Year 02 Month 20 Day
Anticipated trial start date	2015 Year 02 Month 25 Day
Last follow-up date	2018 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	2015 Year 02 Month 10 Day
Last modified on	2021 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019152