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

JRCT ID: jRCT2031190034

Registered date:31/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: High-grade squamous intraepithelial lesions (HSIL/CIN2-3)
• Date of first enrollment: 31/05/2019
• Target sample size: 164
• Study type: Interventional
• Intervention(s): Oral administratio

Outcome(s)

• Primary Outcome: A safety of IGMKK16E7 and pathological regression of HSIL/CIN2-3.
• Secondary Outcome: TH1 immune responses to E7, cytological regression of /CIN2-3, and Clearance of HPV genome.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Female
• Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kawana Kei
• Secondary ID(s): UMIN000034253