UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012980 |
|---|---|
| Receipt number | R000015128 |
| Scientific Title | Study of immunological response in Clinical pharmacological test of BK-SE36/CpG |
| Date of disclosure of the study information | 2014/01/30 |
| Last modified on | 2019/08/16 11:50:47 |
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Basic information
Public title
Study of immunological response in Clinical pharmacological test of BK-SE36/CpG
Acronym
Study of immunological response to BK-SE36/CpG
Scientific Title
Study of immunological response in Clinical pharmacological test of BK-SE36/CpG
Scientific Title:Acronym
Study of immunological response to BK-SE36/CpG
Region
| Japan |
Condition
Condition
Malaria
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objectives are to perform exploratory evaluation of immunogenicity of BK-SE36/CpG malaria vaccine by analyzing antibody function, and to research in parallel biomarker of efficacy and safety of this vaccine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antibody function is analyzed by immunoglobulin subtype assay , antibody dependent cell mediated cytotoxicity assay.
For all of the human microRNA that are registered in miRBase (microRNA Datebase), microRNA expression in sample is analized comprehensively by methods such as microRNA chip, a next-generation sequencer.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
who consent to participate in this clinical study, of subjects of vaccine trials in MRT(medical center for translational and clinical research Osaka university hospital)
Key exclusion criteria
Not obtained the agreement
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Ishii |
Organization
National Institutes of Biomedical Innovation,Health and Nutrition
Division name
Laboratory of Adjuvant Innovation
Zip code
Address
7-6-8 Asagi Saito Ibaraki-City Osaka
TEL
072-641-8043
kenishii@biken.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Ishii |
Organization
National Institutes of Biomedical Innovation,Health and Nutrition
Division name
Laboratory of Adjuvant Innovation
Zip code
Address
7-6-8 Asagi Saito Ibaraki-City Osaka
TEL
072-641-8043
Homepage URL
kenishii@biken.osaka-u.ac.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation,Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
MRT(medical center for translational and clinical research Osaka university hospital)
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 30 | 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
| 2013 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
about serum samples
Blood samples are collected from subjects of vaccine trial in MRT(medical center for translational and clinical research Osaka university hospital),processed to serum,and stored.
Then samples and clinical information not containing personal information are only numbered and transported to National Institute of Biomedical Innovation.
Management information
Registered date
| 2014 | Year | 01 | Month | 27 | Day |
Last modified on
| 2019 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015128
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
