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IRCT20240120060741N1 IRCT 2024-03-26 Nivad Pharmed Salamat Clinical Trial of quadrivalent Papilloguard4 vaccine (Human Papillomavirus Types 6, 11, 16, 18) manufactured by Nivad Pharmed Salamat in comparison with Gardasil Clinical trial of the immunogenicity and safety of Papilloguard 4 vaccine (quadrivalent manufactured by Nivad Pharmed Salamat company) compared to Gardasil vaccine (quadrivalent, reference product, Merck company) by comparing the ratio of GMT (Geometric Mean Titer) in healthy male and female volunteers 15 to 25 years: a phase 3 randomized, parallel, double-blind, noninferiority clinical trial 2024-04-20 anticipated 670 Complete https://irct.ir/trial/75056 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 gender. 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: Both candidate and reference vaccines are pre-filled syringes, but due to the appearance differences of the studied vaccines, before starting the study, all vaccines are placed in the same packages and depending on the sequence, the unique code from the random chain is created on the corresponding coding vaccine packages. By recruitment of volunteers, the unique code is checked by the executive team at first and the related package is taken from the refrigerator and is opened then the vaccine is injected. All participants are injected by educated nurses. According to the vaccine availability In the drug stock of the site and sticking a research label on vaccines and injections by the nurse, the researcher will not be informed about the type of injected vaccine. 3 Genital wart prevention. Intervention 1: Intervention group: intramuscular injection of 0.5ml of quadrivalent papilloma virus vaccine (Nivad 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is The individual data of the participants will not be published publicly except to the relevant authorities and legal organizations.
public Setayesh Sadeghi
National Institute of Genetic Engineering and Biotechnology (NIGEB), Shahrak-e Pajoohesh, km 15, Tehran - Karaj Highway, Tehran, Iran CaRO Pharmed
تهران Iran (Islamic Republic of) 1497719830 +98 21 9120 0238 s.sadeghi@caropharmed.com Caro Pharmed Alborz scientific Masoud Mardani
Makhsus St ,Qazvin St ,Tehran ,Iran
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5102 5000 drmasoudmardani@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Males and females 15 to 25 years old Eligible for general health (through clinical examinations and medical records) Signed the informed consent form (or guardian has signed the informed consent form) It is possible to accompany the visit programs and the study process within 7 months Not having fever (above 37.5°C) or acute infectious disease within 24 hours of participation If the female volunteer had sex within two weeks before entering the study, she must have used a suitable method of prevention (other than emergency pills) Women volunteer must not be pregnant and should agree to use effective preventive method through 7 months of the study Not having a plan to inject other vaccines in the study period (except Meningococcal, hepatitis B, influenza, diphtheria/tetanus vaccines, or injection of diphtheria/tetanus vaccine 8 days before participation with the prior consultation of PI). 15 years 25 years Both Received any prior doses of HPV vaccine A history of severe allergic reactions (swelling of the mouth and throat, dyspnea, hypotension, urticaria, shock) that require therapeutic interventions. History of alcohol or drug abuse (addiction) within 1 year before entering the study Subjects who are thrombocytopenic or suffering from any coagulation disorder that prohibits intramuscular injection. Breastfeeding women Subjects with immune-mediated disease include: splenectomy, subjects who have immune disorders (e.g. lupus, rheumatoid arthritis), currently taking immunosuppressant medication (including radiation therapy, anti-metabolites, taking systemic corticosteroids in the last three weeks more than 15 mg daily), people who are currently undergoing chemotherapy History of chronic diseases e.g. cancer, liver and kidney diseases, chronic lung disease, heart failure, thyroid disorders, neurologic disorders, diabetes, autoimmune disease Receiving immunoglobulins or blood products within 6 months before participation and not having a plan to receive through 7 months of the study. Any other condition outside of the above that, in the opinion of the researcher/doctor, makes the candidate unsuitable for participating in the clinical trial. Participation in other clinical trials A63.0 Anogenital (venereal) warts Prevention Prevention Intervention group: intramuscular injection of 0.5ml of quadrivalent papilloma virus vaccine (Nivad 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 Antibody titer against papillomavirus 6 with GMT comparison after 7 months. Timepoint: After 7 months. Method of measurement: ELISA method. Antibody titer against papillomavirus 11 with GMT comparison after 7 months. Timepoint: After 7 months. Method of measurement: ELISA method. Antibody titer against papillomavirus 16 with GMT comparison after 7 months. Timepoint: After 7 months. Method of measurement: ELISA method. Antibody titer against papillomavirus 18 with GMT comparison after 7 months. Timepoint: After 7 months. 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. Nivad Pharmed Salamat Approved 2024-03-12 research ethics committee of national research ethics committee Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)