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IRCT20190504043464N1 IRCT 2019-05-19 Iran University of Medical Sciences Investigating of the Immunogenicity and Safety of Lactococcus Lactis Vaccine Related to Human Papillomavirus Type 16 Investigation of the Immunogenicity and Safety of Lactococcus Lactis Vaccine Containing Codon-Optimized Full-Length E7 and E6 Oncoproteins of HPV-16 in Healthy Women 2018-12-22 anticipated 200 Complete https://irct.ir/trial/39227 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Volunteers Who Met eligibility Criteria Were Randomized Into Six Clinical Groups in a 2:1 Correlation Using Randomizer Software (Version 3.0) To Receive Four Rounds of Oral Vaccination using the E7 or E6 Vaccine or a Placebo at Weeks 1, 2, 4, and 8. Each Dose of Vaccine was Administered Orally, Once Each Morning After Fasting For Five Days, Each Treatment Week, Blinding description: In This Study, Healthy Women 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. 1 Genital Wart. Intervention 1: Intervention group: Volunteers Receive Four Rounds of Oral Vaccine (1 mL) at Weeks 1, 2, 4, and 8. Each Dose of Vaccine Was 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 (10000000000 CFU/mL), the Dose Was Escalated to 50000000000 CFU/mL and 100000000000 CFU/mL. Intervention 2: Control group: Control Groups Receive Four Rounds of Placebo (1 mL) at Weeks 1, 2, 4, and 8. Each Dose of Placebo Was 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 (10000000000 CFU/mL), the Dose Was Escalated to 50000000000 CFU/mL and 100000000000 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) 1- People Voluntarily Participate in the Research. 2- The Informed Consent Form Is Completed and Signed by the Person or Her companion. 3- Women PCR positive test for Papilloma Virus Infection. 4. Women Don't Have other sexually transmitted diseases. Women Don't be Pregnant 6. Women in Pap smear Test Don't Have Abnormal Conditions. 18 years 59 years Female 1. People Don't Have Cancerous Disease During the Course of Treatment. 2. Failure to Complete a Course of Treatment by Individuals Will Result in Their Exclusion from Study. 3- Getting Pregnant During the Course of Treatment Will Leave Women Out of Study. A63.0 Anogenital (venereal) warts Treatment - Other Treatment - Other Intervention group: Volunteers Receive Four Rounds of Oral Vaccine (1 mL) at Weeks 1, 2, 4, and 8. Each Dose of Vaccine Was 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 (10000000000 CFU/mL), the Dose Was Escalated to 50000000000 CFU/mL and 100000000000 CFU/mL. Control group: Control Groups Receive Four Rounds of Placebo (1 mL) at Weeks 1, 2, 4, and 8. Each Dose of Placebo Was 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 (10000000000 CFU/mL), the Dose Was Escalated to 50000000000 CFU/mL and 100000000000 CFU/mL. Change in Antibody and Interferon Levels. Timepoint: At the Beginning of the Study, 30, 60 and 90 Days After Taking the Vaccine. Method of measurement: ELISA And ELISPOT KITS. 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)