UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034253 |
|---|---|
| Receipt number | 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 | 2022/01/28 12:20:32 |
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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
| Obstetrics 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)
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
ikeda.yuji@nihon-u.ac.jp
Sponsor or person
Institute
School of Medicine, Nihon University
Institute
Department
Personal name
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
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
No longer 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
| 2022 | Year | 06 | Month | 30 | 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
| 2022 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039044
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/07/19 | Protocol_FINAL_MILACLEstudy.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/07/19 | SAP_FINAL_MILACLEstudy.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/07/18 | MILACLEstudy.zip |
Single case data URL
Value
https://center6.umin.ac.jp/ice/39044
