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IRCT20190504043464N2 IRCT 2020-02-07 Iran University of Medical Sciences 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 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 2020-02-01 anticipated 220 Complete https://irct.ir/trial/45040 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible candidates were divided into six clinical groups with a ratio of 2:1 by using Randomizer Software (version 3.0) to receive 4 periods of oral vaccines of E6 or E7 or placebo at weeks 1, 2, 4 and 8 . Each dose of the vaccine was administrated orally, once each morning, and for five days each treatment week. Subjects will be followed for 1 year after each intervention, Blinding description: In this study, women who suffering from cervical intraepithelial neoplasia grade 2/3 are divided into six groups. In this phase, all groups are treated and simultaneously given to three groups of vaccines and given to the other three groups of placebo. 2 Genital Wart. Intervention 1: Intervention group: Volunteers will receive four rounds of oral vaccine (1 mL) at weeks 1, 2, 4, and 8. Each dose of vaccine will be administered orally, once each morning after fasting for five days, each treatment week. If no side effects were detected in arms given the lower dose (1000000000 CFU/mL), the dose will be escalated to 5000000000 CFU/mL and 10000000000 CFU/mL. Intervention 2: Control groups will receive four rounds of placebo (1 mL) at weeks 1, 2, 4, and 8. Each dose of placebo will be administered orally, once each morning after fasting for five days, each treatment week. If no side effects were detected in arms given the lower dose (1000000000 CFU/mL), the dose will be escalated to 5000000000 CFU/mL and 10000000000 CFU/mL. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Amir Hossein Mohseni
Floor 1, Number 498, Shahid Beheshti ave, Tehran.
Tehran Iran (Islamic Republic of) 1596983911 +98 21 8871 6556 amho.mohseni@gmail.com Islamic Azad University scientific Sedigheh Taghinezhad Saroukalaei
Floor 1, No. 498, Shahid Beheshti Ave., Tehran.
Tehran Iran (Islamic Republic of) 1596983911 +98 21 8871 6556 taghinezhad.m@gmail.com Islamic Azad University Iran (Islamic Republic of) 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. 18 years 59 years Female 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. A63.0 Anogenital (venereal) warts Treatment - Other Treatment - Other Intervention group: Volunteers will receive four rounds of oral vaccine (1 mL) at weeks 1, 2, 4, and 8. Each dose of vaccine will be administered orally, once each morning after fasting for five days, each treatment week. If no side effects were detected in arms given the lower dose (1000000000 CFU/mL), the dose will be escalated to 5000000000 CFU/mL and 10000000000 CFU/mL. Control groups will receive four rounds of placebo (1 mL) at weeks 1, 2, 4, and 8. Each dose of placebo will be administered orally, once each morning after fasting for five days, each treatment week. If no side effects were detected in arms given the lower dose (1000000000 CFU/mL), the dose will be escalated to 5000000000 CFU/mL and 10000000000 CFU/mL. Measurement the level of Th1 type IFN-γ 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. 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. Iran University of Medical Sciences Approved 2016-12-20 Iran University of Medical Siences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)