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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034253
Receipt No. R000039044
Scientific Title A Phase I/II study of mucosal immunotherapy using HPV-targeting Lactobacillus-based vaccine, IGMKK16E7, for treatment of HPV16-related high-grade squamous intraepithelial lesions: MILACLE study
Date of disclosure of the study information 2019/01/01
Last modified on 2019/06/07

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Basic information
Public title A Phase I/II study of mucosal immunotherapy using HPV-targeting Lactobacillus-based vaccine, IGMKK16E7, for treatment of HPV16-related high-grade squamous intraepithelial lesions: MILACLE study
Acronym MILACLE study
Scientific Title A Phase I/II study of mucosal immunotherapy using HPV-targeting Lactobacillus-based vaccine, IGMKK16E7, for treatment of HPV16-related high-grade squamous intraepithelial lesions: MILACLE study
Scientific Title:Acronym MILACLE study
Region
Japan

Condition
Condition High-grade squamous intraepithelial lesions (HSIL/CIN2-3)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of oral administration with IGMKK16E7 to patients with HSIL/CIN2-3 and decide the recommended human dose to obtain the optimal efficacy.
Basic objectives2 Others
Basic objectives -Others To examine the relationship between HPV E7 expression levels and the efficacy of IGMKK16E7.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A safety of IGMKK16E7 and pathological regression of HSIL/CIN2-3.
Key secondary outcomes TH1 immune responses to E7, cytological regression of /CIN2-3, and Clearance of HPV genome.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Low-dose of IGMKK16E7 (an attenuated HPV16E7-expressing Lactobacillus casei) is administered daily. All patients received four rounds of oral vaccination at weeks 1, 2, 4, and 8. Each dose of IGMKK16E7 or placebo is administered orally once each morning after fasting for five days each treatment week.
Interventions/Control_2 Middle-dose of IGMKK16E7 (an attenuated HPV16E7-expressing Lactobacillus casei) is administered daily. All patients received four rounds of oral vaccination at weeks 1, 2, 4, and 8. Each dose of IGMKK16E7 or placebo is administered orally once each morning after fasting for five days each treatment week.
Interventions/Control_3 High-dose of IGMKK16E7 (an attenuated HPV16E7-expressing Lactobacillus casei) is administered daily. All patients received four rounds of oral vaccination at weeks 1, 2, 4, and 8. Each dose of IGMKK16E7 or placebo is administered orally once each morning after fasting for five days each treatment week.
Interventions/Control_4 Placebo is administered daily. All patients received four rounds of oral vaccination at weeks 1, 2, 4, and 8. Each dose of IGMKK16E7 or placebo is administered orally once each morning after fasting for five days each treatment week.
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
45 years-old >
Gender Female
Key inclusion criteria 20-45 years-old health female who are diagnosed as HSIL/CIN2 and HSIL/CIN3 by histological examination and infected with HPV 16 alone or HPV16+other types.
Key exclusion criteria (1) Immune compromised host or person who receive immunosuppressive therapy,
(2) Patients who is suspected as invasive cancer,
(3) Patients who has a previous history of hypersensitivity to Lactobacillus-content food/drug or milk,
(4) Pregnant women or patients who expected to get pregnant,
(5) Breast feeder mother.
Target sample size 164

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Kawana
Organization School of Medicine, Nihon University
Division name Department of Obstetrics and Gynecology,
Zip code
Address 30-1, Oyaguchi kami-cho,Itabachi-ku, Tokyo 173-8610, Japan
TEL 03-3972-8111(ext2520)
Email kkawana-tky@umin.org

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Ikeda
Organization School of Medicine, Nihon University
Division name Department of Obstetrics and Gynecology,
Zip code
Address 30-1, Oyaguchi kami-cho,Itabachi-ku, Tokyo 173-8610, Japan
TEL 03-3972-8111(ext2520)
Homepage URL
Email ikeda.yuji@nihon-u.ac.jp

Sponsor
Institute School of Medicine, Nihon University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development,
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor GLOVACC Inc.
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 慶應大学病院(東京都)、筑波大学附属病院(茨城県)、九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 20 Day
Date of IRB
2018 Year 04 Month 27 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 24 Day
Last modified on
2019 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039044

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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