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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013799
Receipt No. R000016095
Scientific Title Safety and efficacy of live attenuated varicella vaccine for preventing varicella zoster virus disease after allogeneic hematopoietic stem cell transplantation: A Prospective Single-Center Study
Date of disclosure of the study information 2014/04/24
Last modified on 2020/04/27

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Basic information
Public title Safety and efficacy of live attenuated varicella vaccine for preventing varicella zoster virus disease after allogeneic hematopoietic stem cell transplantation: A Prospective Single-Center Study
Acronym Live attenuated varicella vaccine after allogeneic HSCT
Scientific Title Safety and efficacy of live attenuated varicella vaccine for preventing varicella zoster virus disease after allogeneic hematopoietic stem cell transplantation: A Prospective Single-Center Study
Scientific Title:Acronym Live attenuated varicella vaccine after allogeneic HSCT
Region
Japan

Condition
Condition Zoster
Classification by specialty
Hematology and clinical oncology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study will be conducted to evaluate the safety and efficacy of live attenuated varicella vaccine for preventing varicella zoster virus disease after allogeneic hematopoietic stem cell transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cumulative incidence of VZV disease
Key secondary outcomes 1)Adverse effect of vaccine
2)VZV antibody titer before and after vaccination
3)VZV specific CTL before and after vaccinations
4)Factors influencing VZV antibody titer and VZV specific CTL

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Live attenuated varicella vaccine (0.5ml SC.) is administered once to allogeneic HSCT patients without active chronic GVHD or ongoing immunosuppressive therapy at 24 months after HSCT. We recommend continuing acyclovir at 200 mg/day until live attenuated varicella vaccine is administered, but the patients who already discontinued acyclovir are permitted to enroll in this study, if they want to do. We propose to measure VZV IgG and VZV specific CTL after 2 weeks, 1 month, 3 months, 6 months, and 1 year.
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
16 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) More than 2 years has passed since allogeneic HSCT
2) Patients without active chronic GVHD or ongoing immunosuppressive therapy
3) ECOG performance status being 0-2
4) The agreement in the document obtained from the person himself about participation in this study (Parental consent is required if patients are < 20 yaers old.)
Key exclusion criteria 1) Patients who have a serious active infection
2) Patients who have a high fever above 37.5 degrees when they receive vaccination
3) Patients who have severe acute illness
4) Patients who experienced an anaphylactic shock due to vaccinations
5) Patients who are or may be pregnant
6) Patients with serious mental disorder
7) Patients who developed VZV disease after allogeneic HSCT
8) Patients with VZV-seronegative before allogeneic HSCT
9) Patients who received inactivated vaccine within 1 week or other live attenuated vaccine within 4 weeks
10) Patients who received transfusions or gamma globulin
Target sample size 31

Research contact person
Name of lead principal investigator
1st name Yoshinobu
Middle name
Last name Kanda
Organization Saitama Medical Center, Jichi Medical University
Division name Division of Hematology
Zip code 330-8503
Address 1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL 048-647-2111
Email ycanda-tky@umin.ac.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Kawamura
Organization Saitama Medical Center, Jichi Medical University
Division name Division of Hematology
Zip code 330-8503
Address 1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL 048-647-2111
Homepage URL
Email k-kawamura0906@jichi.ac.jp

Sponsor
Institute Division of Hematology, Saitama Medical Center, Jichi Medical University
Institute
Department

Funding Source
Organization Div. Hematol, Saitama Medical Center, Jichi Medical Univ.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Medical Center, Jichi Medical University
Address 1-847, Amanuma-cho, Omiya-ku, Saitama-city, Saitam
Tel 0486472111
Email rinri@jichi.ac.jp

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
2014 Year 04 Month 24 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 Enrolling by invitation
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 25 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 24 Day
Last modified on
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016095

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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