Genital wart prevention. Anogenital (venereal) warts
Conditions
Interventions
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 grou
Sponsors
Nivad Pharmed Salamat
Eligibility
Sex/Gender
All
Age
15 Years to 25 Years
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSetayesh Sadeghi
Caro Pharmed Alborz
Outcome results
None listed