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IRCT20230508058114N1 IRCT 2023-05-17 Biosun pharmed pharmaceutical company Clinical study of immunogenicity and safety of human papilloma virus vaccine (quadrivalent, produced by Biosun pharmed Co.) compared to Gardasil vaccine (quadrivalent, produced by Merck Co.) in healthy adults aged 15-35 years Clinical study of immunogenicity and safety of human papilloma virus vaccine (quadrivalent, reference product, produced by Biosun pharmed Co.) compared to Gardasil vaccine (quadrivalent, produced by Merck Co.) in healthy adults aged 15-35 years: A phase 3, randomized, double-blinded, parallel, active-controlled, non-inferiority clinical trial 2023-06-05 anticipated 450 Complete https://irct.ir/trial/70010 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be stratified block randomization, with stratification based on sex. Two strata will be defined, and within each stratum, permuted block randomization will be performed. Permuted randomized blocks with a size of four and a ratio of 1:1 will be created, Blinding description: Due to the different shapes of the vials, the preparation and filling of syringes takes place in a different location than the injection site. The nurse responsible for preparing the vaccines uses identical syringes for all vaccine groups and delivers them to the injection nurse, who is unaware of the vaccine group being administered to the patient. The nurse who evaluates adverse events after vaccination is also blinded to the intervention group. 3 Cervical cancer. Intervention 1: Intervention group: intramuscular injection of 0.5ml of quadrivalent papilloma virus vaccine (Biosun pharmed Co.) in days 0, 60 and 180. Intervention 2: Control group: Intervention group: intramuscular injection of 0.5ml of quadrivalent gardasil vaccine (Merck Co.) in days 0, 60 and 180. 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 ِDecision will be based on the regulatory requirements.
public Hajar Mohamadi
Biosun pharmed production site, Kermani st., Moalem st., Yaftabad.
Tehran Iran (Islamic Republic of) 1111111111 +98 912 546 8094 Ha.Mohammadi@Biosunpharmed.com Biosun pharmed pharmaceutical Co. scientific Minoo Mohraz
Tehran Hospital, Sanayi square, Hoseini St. Karimkhan st, 7-tir square
Tehran Iran (Islamic Republic of) 1585737311 009888821021 minoomohraz@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age 15-35 years, Both genders The volunteer and/or their guardian have the ability to understand the conduct process of the study and the willingness to attend visits, injections, and other processes in the protocol. The volunteer and/or their guardian have the ability to fully understand the contents of the informed consent form and sign it before entering the study. General health confirmed by medical history and physical examination by physician. Not having infection and inflammation in uterus or genital area based on physician examination. Not having fever (Temperature >37.5 C) or an acute infectious disease in the last 24 hours before injection Not having a plan to inject other vaccines in the study period (meningococcus, hepatitis B, Inactive influenza, Covid-19 and dT containing vaccines are allowed until 8 days before HPV vaccine) Not using vaginal products or having sexual intercourse 48 hours before each visit Using Contraception method (other than emergency pills) in case of sexual intercourse in two weeks before study entry Seronegative for Anti HPV 6,11,16,18 Not being pregnant (Blood beta hCG) and agree to use contraception method for 7 months. 15 years 35 years Both History of abnormal pap smear or biopsy Having or the history of having genital wart History or active HPV infection Prior HPV vaccination History of any vaccine injection in the last 21 days before study entry History of severe allergic reactions to vaccine which needs treatment. History of hypersensitivity to vaccine ingredients Receiving immunoglobulins or blood products in the six months prior to study entry or having a plan to use them in the seven months following study entry. Chronic diseases such as liver, renal, uncontrolled hypertension, diabetes mellites type 1 or 2, gestational diabetes, chronic pulmonary diseases, heart failure, thyroid diseases, neurologic diseases and malignancies Immunodeficiency or immune related disorders Thrombocytopenia or any coagulation disorder with contraindication for IM injection History of drug or alcohol abuse in the 12 months prior to study entry. Severe psychiatric diseases affecting the study participatin Intention for pregnancy in the following 7 months Concurrent participation in other studies Any other conditions that make the volunteer unsuitable for the study (Investigator opinion) For second and third injection: Severe adverse events related to the previous injections C53 Malignant neoplasm of cervix uteri Prevention Prevention Intervention group: intramuscular injection of 0.5ml of quadrivalent papilloma virus vaccine (Biosun pharmed Co.) in days 0, 60 and 180 Control group: Intervention group: intramuscular injection of 0.5ml of quadrivalent gardasil vaccine (Merck Co.) in days 0, 60 and 180 Human papilloma virus type 16 antibody titer, GMT. Timepoint: Seven months after first injection. Method of measurement: ELISA method. Human papilloma virus type 18 antibody titer, GMT. Timepoint: Seven months after first injection. Method of measurement: ELISA method. Human papilloma virus type 6 antibody titer, GMT. Timepoint: Seven months after first injection. Method of measurement: ELISA method. Human papilloma virus type 11 antibody titer, GMT. Timepoint: Seven months after first injection. Method of measurement: ELISA method. Seroconversion in human papilloma virus antibody types 6, 11, 16 and 18. Timepoint: Days 60, 180 and 210 after first injection. Method of measurement: Four-fold increase in antibody titer. Human papilloma virus type 16 antibody titer, GMT. Timepoint: Days 60 and 180 after first injection. Method of measurement: ELISA method. Human papilloma virus type 18 antibody titer, GMT. Timepoint: Days 60 and 180 after first injection. Method of measurement: ELISA method. Human papilloma virus type 6 antibody titer, GMT. Timepoint: Days 60 and 180 after first injection. Method of measurement: ELISA method. Human papilloma virus type 11 antibody titer, GMT. Timepoint: Days 60 and 180 after first injection. Method of measurement: ELISA method. Any solicited local or systemic acute or allergic adverse event. Timepoint: During the first 30 minutes after each vaccine injection. Method of measurement: Direct observation and reporting. Any solicited local or systemic adverse event. Timepoint: During the first 7 days after each vaccine injection. Method of measurement: Direct observation and reporting. Any unsolicited adverse events. Timepoint: During the first 30 days after each vaccine injection. Method of measurement: Direct observation and reporting. Any serious adverse event. Timepoint: During the first 30 days after each vaccine injection. Method of measurement: Direct observation and reporting. Biosun pharmed pharmaceutical company Approved 2023-05-06 National research ethics committee 13th floor, Block A, Ministry of health, Simaye Iran street, Shahrake ghods(qarb) Tehran Tehran Iran (Islamic Republic of)