Cervical cancer. Malignant neoplasm of cervix uteri
Conditions
Interventions
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 gro
Sponsors
Biosun pharmed pharmaceutical company
Eligibility
Sex/Gender
All
Age
15 Years to 35 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
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 ContactHajar Mohamadi
Biosun pharmed pharmaceutical Co.
Outcome results
None listed