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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018001
Receipt No. R000020832
Scientific Title A phase I clinical trial of rice-based oral cholera vaccine IMSUT-MR1501 in healthy volunteers
Date of disclosure of the study information 2015/06/23
Last modified on 2017/03/31

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Basic information
Public title A phase I clinical trial of rice-based oral cholera vaccine IMSUT-MR1501 in healthy volunteers
Acronym A phase I clinical trial of rice-based oral cholera vaccine IMSUT-MR1501
Scientific Title A phase I clinical trial of rice-based oral cholera vaccine IMSUT-MR1501 in healthy volunteers
Scientific Title:Acronym A phase I clinical trial of rice-based oral cholera vaccine IMSUT-MR1501
Region
Japan

Condition
Condition cholera, travelers' diarrhea
Classification by specialty
Medicine in general Gastroenterology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) Assessment of the safety and tolerance of IMSUT-MR1501 administered orally every other week for a total of 4 doses.
2) Exploratory evaluation of immunological effects of IMSUT-MR1501, in order to identify efficacy endpoints for future clinical trials.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes The safety of IMSUT-MR1501 is evaluated for 16 weeks, based on the assessment of adverse events, vital signs (body temperature, blood pressure, and pulse rate), electrocardiograms, and laboratory tests including serum IgE antibodies specific to rice proteins.
Key secondary outcomes Immunological effects of IMSUT-MR1501 are preliminarily evaluated by analyzing the levels of serum IgG/IgA antibodies and fecal IgA antibodies specific to cholera toxin B subunit (CTB) and antibody-producing B lymphocytes.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Sequential-cohort dose-escalation trial (3 dose-escalation cohorts of 20 subjects). In each cohort, 10 subjects are randomly assigned to the IMSUT-MR1501 arm, and IMSUT-MR1501 is administered orally every other week for a total of 4 doses. Dosing is as follows:
Cohort 1 1 g of IMSUT-MR1501
Cohort 2 3 g of IMSUT-MR1501
Cohort 3 6 g of IMSUT-MR1501
Interventions/Control_2 Sequential-cohort dose-escalation trial (3 dose-escalation cohorts of 20 subjects). In each cohort, 10 subjects are randomly assigned to the Placebo arm, and Placebo is administered orally every other week for a total of 4 doses. Dosing is as follows:
Cohort 1 1 g of Placebo
Cohort 2 3 g of Placebo
Cohort 3 6 g of Placebo
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
40 years-old >=
Gender Male
Key inclusion criteria 1) Able and willing to give valid written informed consent
2) Healthy Japanese male aged 20-40
3) Measurable serum and fecal antibodies against CTB
Key exclusion criteria 1) History of allergy to rice
2) History of cholera and/or travellers' diarrhea
3) Constipation with poor responses to laxative treatment
4) Abnormal results on hepatic, renal, and/or hematologic screening tests
5) Use of any prescription drugs within 14 days before dosing and/or any over-the-counter drugs within 7 days before dosing
6) Unable or unwilling to use medically acceptable means of contraception
7) Any condition that, in the Investigator's opinion, might not be suitable for the trial
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotoshi Tanaka
Organization IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Division name Department of Rheumatology and Allergy
Zip code
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
TEL 03-3443-8111
Email dctsm@ims.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Center for Translational Research
Organization IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Division name Center for Translational Research
Zip code
Address 4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
TEL 03-5449-5462
Homepage URL http://www.ims.u-tokyo.ac.jp/tr/entry.html
Email dctsm@ims.u-tokyo.ac.jp

Sponsor
Institute IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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 2015年5月7日、初回

Institutions
Institutions 東京大学医科学研究所附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 23 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
2015 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 30 Day
Last follow-up date
2016 Year 05 Month 11 Day
Date of closure to data entry
2016 Year 12 Month 16 Day
Date trial data considered complete
2016 Year 12 Month 16 Day
Date analysis concluded
2016 Year 12 Month 16 Day

Other
Other related information

Management information
Registered date
2015 Year 06 Month 22 Day
Last modified on
2017 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020832

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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