cervical cancer. Malignant neoplasm of cervix uteri
Conditions
Interventions
Intervention 1: Intervention group: Candidate vaccine: pre-filled vaccine syringe of HPV vaccine 16,18 (manufactured by Noyan Pajouhan Biopharma) 20 g HPV-16 L1 VLP/20 g HPV-18 L1 VLP intramuscular in
Sponsors
Noyan Pajouhan biopharma
Eligibility
Sex/Gender
Female
Age
15 Years to 25 Years
Inclusion criteria
Inclusion criteria: Female subjects between, and including, 15 to 25 years of age at the time of the first vaccination Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study Subjects that have an intact uterus and cervix Written informed consent obtained from the subject prior to enrollment. Subjects who can and will comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: Previous vaccination against HPV History of allergic reaction to vaccine administration Chronic administration of immune-suppressants (more than 14 days) or other immune-modifying drugs within six months prior to the first vaccine dose. Planned administration of a vaccine not foreseen by the study protocol. Any confirmed or suspected immunosuppressive or immunodeficient condition (based on medical history and physical examination). Known chronic disease such as Cancer, hepatic or renal disease, neurologic disease, diabetes or autoimmune diseases Administration of immunoglobulin and/or any blood products within the 90 days preceding the first dose of study vaccine Positive ß-HCG test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody titre against papillomavirus 16,18 with GMT comparison after 7 months. Timepoint: After 7 months. Method of measurement: Geometric Mean Titre. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with seroconversion against HPV 16 and 18. Timepoint: Number of females with seroconversion after 6 months of first injection. Method of measurement: For seroconversion of type 16,18 Human papillomavirus measure the ratio of level of threshold of antibody against human papillomavirus 16,18 to total population in percentage.;Percentage of any adverse effects. Timepoint: Solicited adverse effects after one week of each injection; Unsolicited adverse effects after one month of each injection;. Method of measurement: Solicited, unsolicited and serious adverse event: ratio of events to total study population in percentage. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Aminipouya
Arta zist pharmed
Outcome results
None listed