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
- Conditions
- High-grade squamous intraepithelial lesions (HSIL/CIN2-3)1. Human papillomavirus (HPV)2. Cervical cancer 3. Cervical intraepithelial neoplasia 4. Therapeutics 5. Immunotherapy 6. Mucosal immunity 7. Oral administration 8. Lactobacillus casei (L. casei) 9. Clinical trial Phase I/II 10. Predictive biomarker
- Registration Number
- JPRN-jRCT2031190034
- Lead Sponsor
- Kawana Kei
- Brief Summary
In a double-blind, placebo-controlled, randomized trial, 165 patients with HPV16-positve high-grade cervical intraepithelial neoplasia (CIN2/3) were assigned to orally-administered placebo, or low-, intermediate-, or high-doses of IGMKK16E7 (lacticaseibacillus paracasei expressing cell surface, full-length HPV16E7). In all four groups, IGMKK16E7 or placebo was administered orally at weeks 1, 2, 4 and 8 post-enrollment. The primary outcomes included histopathological regression and IGMKK16E7 safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 165
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.
(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
- Secondary Outcome Measures
Name Time Method