UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018001
Receipt number 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 2022/12/15 11:23:42

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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 or person

Institute

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

Institute

Department

Personal name



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

2022 Year 12 Month 15 Day



Link to view the page

Value
https://center6.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