UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013799 |
|---|---|
| Receipt number | 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 09:00:08 |
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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
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
k-kawamura0906@jichi.ac.jp
Sponsor or person
Institute
Division of Hematology, Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016095
