UMIN-CTR Clinical Trial

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

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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 or person

Institute

Fukkuoka Blood and Marrow Transplantation Group

Institute

Department

Personal name



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

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