UMIN-CTR Clinical Trial

Basic information
Public title	The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to Cervical Intraepithelial Neoplasia 3 (CIN3).
Acronym	The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to CIN3.
Scientific Title	The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to Cervical Intraepithelial Neoplasia 3 (CIN3).
Scientific Title:Acronym	The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to CIN3.
Region	Japan

Condition
Condition	Cervical Intraepithelial Neoplasia 3 (CIN3)
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It aims at the first drug therapy to CIN3 by inducing the mucosal cellular immunity to HPV oncoprotein E7 with the oral vaccine using lactobacillus. In this research, it aims to confirm safety and effectiveness of this therapeutic HPV vaccine.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical safety and efficacy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	The therapeutic HPV vaccine will be taken in 20 days (1st to 5th, 8th to 12th, 22nd to 26th and 50th to 54th day) within all administering period (8 weeks). The dosage is assumed to be 1 to 6 capsule/time/a day.
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	50 years-old >
Gender	Female
Key inclusion criteria	1) HPV16 infected women 2) whom can observe all lesioned part by colposcopic inspection 3) whom hope for conization of the cervix by patients judged that conization of the cervix is necessary 4) whom of 20 ~ 50 years old when agreement is acquired. 5) outpatient 6) All patients were required to provide written informed consent.
Key exclusion criteria	1) Person who has obviously received prohibition of using together medicine (treatment) that causes person and immune suppression that has disease that abnormality is found in immune function 2) patients of class5 in cervical cytology. 3) whom hope for laser ablation 4) patients with serious acute illness 5) patients that there are previous histories of hypersensitivity in lactobacillus content food (yogurt etc.) and preparation of lactobacillus 6) patients who has allergy for milk 7) pregnant or expected to be pregnant 8) breast feeding mother 9) whom administered other trial drugs within three months before initiation of this trial study 10) whom administered this medicine 11) whom the investigator think inappropriate as a candidate.
Target sample size	17

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kei Kawana
Organization	The University of Tokyo Hospital
Division name	Department of Obstetrics & Gynecology
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	The University of Tokyo Hospital
Division name	Department of Obstetrics & Gynecology
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute	The University of Tokyo Hospital Department of Obstetrics & Gynecology
Institute
Department

Funding Source
Organization	GENOLAC BL Corp.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2009 Year 02 Month 06 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	2008 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date	2009 Year 02 Month 01 Day
Last follow-up date	2014 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 02 Month 04 Day
Last modified on	2013 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002033

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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