High-grade squamous intraepithelial lesions (HSIL/CIN2-3)
Conditions
Interventions
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 IGMKK1
Sponsors
School of Medicine, Nihon University
GLOVACC Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A safety of IGMKK16E7 and pathological regression of HSIL/CIN2-3. | — |
Secondary
| Measure | Time frame |
|---|---|
| TH1 immune responses to E7, cytological regression of /CIN2-3, and Clearance of HPV genome. | — |
Countries
Japan
Contacts
Public ContactYuji Ikeda
School of Medicine, Nihon University Department of Obstetrics and Gynecology,
Outcome results
None listed