UMIN-CTR Clinical Trial

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
Email	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
Email	kenishii@biken.osaka-u.ac.jp

Sponsor
Institute	National Institutes of Biomedical Innovation,Health and Nutrition
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015128