A Phase I Study of Quadrivalent HPV Recombinant Vaccine

Study Overview
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Brief Summary
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To evaluate the safety and primary immunogenicity of the quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (hansenula polymorpha) in Chinese female subjects aged 9-45 years.

Official Title
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A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Primary Immunogenicity of the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years

Conditions
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HPV Infections

Intervention / Treatment
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* Biological: HPV vaccine
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy females between, and including, 9 and 45 years of age at the time of enrolment Be able to provide legal identification for the sake of recruitment Be able to understand and sign informed consent form prior to enrollment and for subjects aged 9-17 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together Subjects who the investigator believes that they can and will comply with the protocol requirements Subject must be not pregnant at the enrollment and agree to use adequate contraceptive precautions within 7 months or don't have pregnancy plan Exclusion Criteria: Fever or axillary temperature> 37.0℃ before vaccination Previous vaccination against HPV, or planned administration/administration of a vaccine not foreseen by the study protocol within 30 days preceding first dose of vaccine; Planned to take part in other clinical research within 7 months after participating this study Abnormal laboratory tests parameters Administration of any whole blood, plasma or immunoglobulins products within 3 months preceding first vaccination Interval between administration of the study vaccination and any attenuated live vaccine less than 14 days, and other vaccines less than 10 days History of serious allergic disease requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock) History of to adverse event to vaccine, or allergic to some food or drug History of epilepsy, seizures or convulsions, or family history of mental illness Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose. Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy Subject to severe hepatorenal disease, cardiovascular disease, hypertension, diabetes, malignant tumor, all kinds of infectious diseases and acute illness, or during chronic disease acute attack period Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder During menstrual period or acute disease period of onset Breastfeeding, pregnancy (including pregnancy test positive), or planned to be pregnant within 7 months Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that relevant to HPV infection in the past two years Planned to moveout of local before the end of the study or leave the local for a long time during the study period Other unsuitable factors for the study judged by investigators

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV vaccine<br>Subjects received 3 doses of HPV vaccine according to a 0, 2, 6-month schedule. | Biological: HPV vaccine<br> <br> |
| Placebo Comparator: Placebo<br>Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule. | Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic and local adverse events during the period of first dose vaccination to 30 days after last dose of vaccination |  | 30 days after last dose of vaccination |