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
Not Applicable
- Conditions
- High-grade squamous intraepithelial lesions (HSIL/CIN2-3)
- Registration Number
- JPRN-UMIN000034253
- Lead Sponsor
- School of Medicine, Nihon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 164
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A safety of IGMKK16E7 and pathological regression of HSIL/CIN2-3.
- Secondary Outcome Measures
Name Time Method TH1 immune responses to E7, cytological regression of /CIN2-3, and Clearance of HPV genome.