Evaluate the Safety of Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Healthy Females

Phase 1

• Conditions: Human Papillomavirus
• Interventions: Biological: HPV 16/18 vaccine, 0,5ml; Biological: Placebo control, 0.5ml; Biological: HPV 16/18 vaccine, 1.0ml; Biological: Placebo control, 1.0ml

• Registration Number: NCT01548118
• Lead Sponsor: Shanghai Zerun Biotechnology Co.,Ltd

Brief Summary

This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-29
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-05
• Last Update Submitted: 2012-03-05
• Study First Posted: 2012-03-08
• Last Update Posted: 2012-03-08
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Healthy female between, and including, 9 and 45 years of age at the time of the first vaccination
• Provide legal identification for for the sake of recruitment.
• Be able to understand and sign informed consent prior to enrollment (For subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition).
• Subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months.

Exclusion Criteria

• History of cervical cancer
• History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
• History of allergic to vaccine, or to any ingredient of vaccine.
• 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.
• History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant
• Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
• Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
• Acute disease or chronic disease acute exacerbation 7 days prior to vaccination
• Administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days.
• Fever or axillary temperature> 37.0 °C before vaccination
• During menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned pregnant within 7 month
• History of hypertension, physical examination systolic blood pressure> 150mmHg and/or diastolic blood pressure> 100mmHg
• Abnormal laboratory tests parameters
• Any clinical significant disease or findings during study screening that, in the opinion of the Investigator may interfere with the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adult Group 1, HPV vaccine 0.5ml	HPV 16/18 vaccine, 0,5ml	20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines.
Adult Group 1, Placebo 0.5ml	Placebo control, 0.5ml	20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate.
Adult Group 2, HPV vaccine 1.0ml	HPV 16/18 vaccine, 1.0ml	20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines.
Adult Group 2, Placebo 1.0ml	Placebo control, 1.0ml	20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate.
Children Group 1, HPV vaccine 0.5ml	HPV 16/18 vaccine, 0,5ml	20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines.
Children Group 1, Placebo 0.5ml	Placebo control, 0.5ml	20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate.
Children Group 2, HPV vaccine 1.0ml	HPV 16/18 vaccine, 1.0ml	20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines.
Children Group 2, Placebo 1.0ml	Placebo control, 1.0ml	20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate.

Primary Outcome Measures

Name	Time	Method
Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions.	7 days after each vaccine dose
Occurrence, intensity and relationship to vaccination of any unsolicited symptom.	30 days after finish vaccinations

Secondary Outcome Measures

Name	Time	Method
Neutralizing antibody responses of HPV 16/18 after each vaccine dose.	30 days after finish vaccinations

Trial Locations

Locations (1)

GuangXi Center for Diseases Control and Prevention; 🇨🇳 Nanning, Guangxi, China