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

A Blind, Randomized and Placebo-controlled Clinical Trial With Recombinant HumanPapillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Health Women-Phase I

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China
      • GuangXi Center for Diseases Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adult Group 1, HPV vaccine 0.5ml; 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines.	Biological: HPV 16/18 vaccine, 0,5ml; Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Placebo Comparator: Adult Group 1, Placebo 0.5ml; 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate.	Biological: Placebo control, 0.5ml; Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Experimental: Adult Group 2, HPV vaccine 1.0ml; 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines.	Biological: HPV 16/18 vaccine, 1.0ml; Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Placebo Comparator: Adult Group 2, Placebo 1.0ml; 20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate.	Biological: Placebo control, 1.0ml; Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Experimental: Children Group 1, HPV vaccine 0.5ml; 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines.	Biological: HPV 16/18 vaccine, 0,5ml; Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Placebo Comparator: Children Group 1, Placebo 0.5ml; 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate.	Biological: Placebo control, 0.5ml; Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Experimental: Children Group 2, HPV vaccine 1.0ml; 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines.	Biological: HPV 16/18 vaccine, 1.0ml; Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Placebo Comparator: Children Group 2, Placebo 1.0ml; 20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate.	Biological: Placebo control, 1.0ml; Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Neutralizing antibody responses of HPV 16/18 after each vaccine dose.	30 days after finish vaccinations

Collaborators and Investigators

• Sponsor: Shanghai Zerun Biotechnology Co.,Ltd
• Investigators: Principal Investigator: Yan-ping Li, MD, Guangxi Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: February 29, 2012
• First Submitted That Met QC Criteria: March 5, 2012
• First Posted (Estimate): March 8, 2012

Study Record Updates

• Last Update Posted (Estimate): March 8, 2012
• Last Update Submitted That Met QC Criteria: March 5, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: vaccine; Human papillomavirus; cervical cancer; cervical infection
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 311-HPV-1001