Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

This study has been completed.
Sponsor:
Collaborators:
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Information provided by (Responsible Party):
Jun Zhang, Xiamen University
ClinicalTrials.gov Identifier:
NCT01263327
First received: December 17, 2010
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.


Condition Intervention Phase
Cervical Cancer
Biological: HPV 16/18
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-Label, Single-dose, Non-Randomized, Safety and Tolerability Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 55 Years

Resource links provided by NLM:


Further study details as provided by Xiamen University:

Primary Outcome Measures:
  • Measure injection-site complaints within 7 days after each vaccination; Measure systematic adverse reactions within 1 month after vaccination; Measure serious adverse experience; Measure blood, liver and kidney functions pre- and 3 days post vaccination. [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPV 16/18
Participants in this arm would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Biological: HPV 16/18
Participants would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent from the subject prior to enrolment;
  • Female between, and including, 18 and 55 years of age at the time of enrolment;
  • Subjects must be free of obvious health problems;
  • Not pregnant and having no plan for pregnancy;

Exclusion Criteria:

  • Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
  • Previous vaccination against HPV;
  • Having severe allergic history or other immunodeficiency;
  • Chemotherapy and other immunosuppressive agents using;
  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: NCT01263327

Locations
China, Jiangsu
Jiangsu Provincial Centre for Disease Control and Prevention
Dongtai, Jiangsu, China, 224200
Sponsors and Collaborators
Xiamen University
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Investigators
Principal Investigator: Yue-mei Hu, Bachelor Jiangsu Provincial Centre for Disease Control and Prevention
  More Information

Publications:
Responsible Party: Jun Zhang, Professor, Xiamen University
ClinicalTrials.gov Identifier: NCT01263327     History of Changes
Other Study ID Numbers: HPV-PRO-001
Study First Received: December 17, 2010
Last Updated: February 20, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xiamen University:
human papillomavirus vaccine

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014