Phase II Clinical Trial of Safety, Immunogenicity, and Mucosal Immunotherapy of Recombinant Lactococcus lactis Expressing Human Papillomavirus Type 16 E6/E7 Oncoprotein Vaccine (KMTLL16E6/7) in Women Suffering From Cervical Intraepithelial Neoplasia (CIN) Grade 2/3

Iran University of Medical Sciences0 个研究点目标入组 220 人开始时间: 待定最近更新: 2020年2月24日

适应症

试验速览

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•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.

•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.

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