Unique ID issued by UMIN | UMIN000001686 |
---|---|
Receipt number | R000002033 |
Scientific Title | The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to Cervical Intraepithelial Neoplasia 3 (CIN3). |
Date of disclosure of the study information | 2009/02/06 |
Last modified on | 2013/11/07 17:10:48 |
The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to Cervical Intraepithelial Neoplasia 3 (CIN3).
The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to CIN3.
The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to Cervical Intraepithelial Neoplasia 3 (CIN3).
The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to CIN3.
Japan |
Cervical Intraepithelial Neoplasia 3 (CIN3)
Obstetrics and Gynecology |
Others
NO
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.
Safety,Efficacy
Clinical safety and efficacy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Vaccine |
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.
20 | years-old | <= |
50 | years-old | > |
Female
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.
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.
17
1st name | |
Middle name | |
Last name | Kei Kawana |
The University of Tokyo Hospital
Department of Obstetrics & Gynecology
7-3-1 Hongo, Bunkyo-ku, Tokyo
1st name | |
Middle name | |
Last name |
The University of Tokyo Hospital
Department of Obstetrics & Gynecology
7-3-1 Hongo, Bunkyo-ku, Tokyo
The University of Tokyo Hospital
Department of Obstetrics & Gynecology
GENOLAC BL Corp.
Profit organization
NO
2009 | Year | 02 | Month | 06 | Day |
Unpublished
Completed
2008 | Year | 12 | Month | 08 | Day |
2009 | Year | 02 | Month | 01 | Day |
2014 | Year | 02 | Month | 01 | Day |
2009 | Year | 02 | Month | 04 | Day |
2013 | Year | 11 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002033