UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006471 |
|---|---|
| Receipt number | 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 17:06:41 |
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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
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
tkumamjp@yahoo.co.jp
Sponsor or person
Institute
Department of Pediatric and Developmental Science, Institute of Molecular and Experimental Medicine, Mie University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007679
