Phase II Clinical Trial of Safety, Immunogenicity, and Mucosal Immunotherapy of Recombinant Lactococcus lactis Expressing Human Papillomavirus Type 16 E6/E7 Oncoprotein Vaccine in Women having Cervical Intraepithelial Neoplasia (CIN)

Phase 2

Recruiting

• Conditions: Genital Wart.; Anogenital (venereal) warts; A63.0

• Registration Number: IRCT20190504043464N2
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

The women must have the ability to understand the study requirements, sign the Informed Consent Form, and also understand all restrictions during the study.
18-59 years-old females who are diagnosed as CIN2/3 by histological examination and are infected with HPV-16 alone or HPV-16 plus other types have the eligibility to enter in the study
Women shouldn't have other sexually transmitted diseases.
Women shouldn't be pregnant before starting the study.
Women shouldn't have other cancerous disease.

Exclusion Criteria

Patients who has a previous history of hypersensitivity to probiotic-content (food/drug or milk).
Patients who are suspected to invasive cancers.
Patients with the medical history of diseases that may endanger the safety of the participant.
Patients with a history of allergic diseases or reactions that may be aggravated by any component of the vaccine in question.
Patients who have plan to do surgery during the study.
Patients who used antibacterial drugs in 14-28 days before the study.
Patients who used any vaccine within 90 days prior to screening.
Patients who have plan to participate in another clinical trial during the present trial study.
Patients who have autoimmune diseases or immunosuppressive disease.
Patients with positive results of the HIV-1/2 antibodies, HCV antibody, HSV antibody, and HBsAg on screening process will be excluded from the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Examination of cervix and vagina for evaluating and predicting the malignant and CIN status in treated women. Timepoint: At the Beginning of the Study (on day 0 before the initial vaccination), at day 60 after taking the vaccine, and at months 1, 6, and 12 after the last vaccination. Method of measurement: Colposcopy and Cervical Biopsy.;Measurement the level of Th1 type IFN-? and antigen-specific CTLs secretion in PBMC and vaginal fluids. Timepoint: At the Beginning of the Study (on day 0 before the initial vaccination), at day 60 After Taking the Vaccine., and at months 1, 6, and 12 after the last vaccination. Method of measurement: ELISPOT KITS.;Determining the presence/absence of HPV-16 in cervical fluids. Timepoint: At the Beginning of the Study (on day 0 before the initial vaccination), at day 60 after taking the vaccine, and at months 1, 6, and 12 after the last vaccination. Method of measurement: PCR and INNO-LiPA Techniques.