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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006471
Receipt No. R000007679
Scientific Title A Phase I Clinical Study of Dendritic Cell Vaccine against Measles for Patients Following Hematopoietic Cell Transplantation
Date of disclosure of the study information 2011/10/04
Last modified on 2011/10/04

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Basic information
Public title A Phase I Clinical Study of Dendritic Cell Vaccine against Measles for Patients Following Hematopoietic Cell Transplantation
Acronym DC vaccine against Measles
Scientific Title A Phase I Clinical Study of Dendritic Cell Vaccine against Measles for Patients Following Hematopoietic Cell Transplantation
Scientific Title:Acronym DC vaccine against Measles
Region
Japan

Condition
Condition Post-HCT patients
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of DC vaccine against measles for post-HCT patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Adverse events
Key secondary outcomes serum-anti measles antibody titer

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are 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 until 6 weeks after DC vaccine against measles, 0.2 to 5 million DCs, single subcutaneous inoculation.
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
1 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Provide signed, written informed consent.
2. be a post-HCT patient
3. Serum anti-measles antibody should be negative.
4. Have a Eastern Cooperative Oncology Group Performance Status (PS) of 0-2.
5. Have adequate liver, renal, and cardiac function.
Key exclusion criteria 1. Have a recurrent or relapse of their diseases
2. Are pregnant or lactating.
3. Have psychiatric disorders that would interfere with consent, study participation, or follow-up.
4. Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or pancreas.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Kumamoto
Organization Mie University Graduate School of Medicine
Division name Department of Pediatric and Developmental Science, Institute of Molecular and Experimental Medicine
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-232-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Kumamoto
Organization Mie University Graduate School of Medicine
Division name Department of Pediatric and Developmental Science, Institute of Molecular and Experimental Medicine
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-232-1111
Homepage URL
Email tkumamjp@yahoo.co.jp

Sponsor
Institute Department of Pediatric and Developmental Science, Institute of Molecular and Experimental Medicine, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Pediatric and Developmental Science, Institute of Molecular and Experimental Medicine, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 三重大学医学部附属病院小児科

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 04 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 DC-based MV vaccine could be safely inoculated and would be effective in post-HCT patients.
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
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 04 Day
Last modified on
2011 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007679

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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