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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Shanghai Zerun Biotechnology Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01548118
First received: February 29, 2012
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Human Papillomavirus
Biological: HPV 16/18 vaccine, 0,5ml
Biological: Placebo control, 0.5ml
Biological: HPV 16/18 vaccine, 1.0ml
Biological: Placebo control, 1.0ml
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Blind, Randomized and Placebo-controlled Clinical Trial With Recombinant HumanPapillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Health Women-Phase I

Resource links provided by NLM:


Further study details as provided by Shanghai Zerun Biotechnology Co.,Ltd:

Primary Outcome Measures:
  • Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions. [ Time Frame: 7 days after each vaccine dose ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and relationship to vaccination of any unsolicited symptom. [ Time Frame: 30 days after finish vaccinations ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Neutralizing antibody responses of HPV 16/18 after each vaccine dose. [ Time Frame: 30 days after finish vaccinations ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   9 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548118

Locations
China, Guangxi
GuangXi Center for Diseases Control and Prevention
Nanning, Guangxi, China
Sponsors and Collaborators
Shanghai Zerun Biotechnology Co.,Ltd
Investigators
Principal Investigator: Yan-ping Li, MD Guangxi Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Shanghai Zerun Biotechnology Co.,Ltd
ClinicalTrials.gov Identifier: NCT01548118     History of Changes
Other Study ID Numbers: 311-HPV-1001
Study First Received: February 29, 2012
Last Updated: March 5, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Zerun Biotechnology Co.,Ltd:
Human papillomavirus
vaccine
cervical infection
cervical cancer

ClinicalTrials.gov processed this record on July 29, 2014