Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

This study is ongoing, but not recruiting participants.
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:
NCT01356823
First received: May 13, 2011
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine expressed in E. coli.

The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce higher antibody and at the same time caused less adverse events.

The secondary purpose of this study is to to evaluate the safety and immunopersistence of the study vaccine.


Condition Intervention Phase
Cervical Intraepithelial Neoplasia
Cervical Cancer
Biological: 30μg HPV
Biological: 60μg HPV
Biological: 90μg HPV
Biological: Hepatitis B vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 25 Years

Resource links provided by NLM:


Further study details as provided by Xiamen University:

Primary Outcome Measures:
  • Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.


Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    All the adverse events in one month after each dose would be recorded in the diary card. All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded.


Enrollment: 1600
Study Start Date: March 2011
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 30μg HPV
Participants in this arm would receive 30μg HPV vaccines which contains 20μg HPV 16 antigen and 10μg HPV 18 antigen
Biological: 30μg HPV
Participants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Experimental: 60μg HPV
Participants in this arm would receive 60μg HPV vaccines which contains 40μg HPV 16 antigen and 20μg HPV 18 antigen
Biological: 60μg HPV
Participants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Experimental: 90μg HPV
Participants in this arm would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
Biological: 90μg HPV
Participants would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
Placebo Comparator: hepatitis B vaccine
Participants in this arm would receive hepatitis B vaccine.
Biological: Hepatitis B vaccine
Participants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.

Detailed Description:

Totally 1600 healthy women of 18-25 years of age were enrolled. The participants were randomly stratified into 4 groups and receive different dosage of human papillomavirus (HPV) vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule. The women were actively monitored for adverse events for 1 month after each injection. Severe adverse events during the trial were followed up. Serum samples from all the subjects would be collected on day 0, 7m, 24m, 48m and 72m to evaluate the immunogenicity and immuno-persistency.

  Eligibility

Ages Eligible for Study:   18 Years to 25 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 25 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: NCT01356823

Locations
China, Jiangsu
Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Xiamen University
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Investigators
Study Chair: Jun Zhang, Master Xiamen University
Principal Investigator: Yuemei Hu, Bachelor Jiangsu Provincial Centre for Disease Control and Prevention
Study Director: Ting Wu, Ph. D Xiamen University
  More Information

No publications provided

Responsible Party: Jun Zhang, professor, Xiamen University
ClinicalTrials.gov Identifier: NCT01356823     History of Changes
Other Study ID Numbers: HPV-PRO-002
Study First Received: May 13, 2011
Last Updated: February 21, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xiamen University:
Human Papilloma Virus 16
Human Papilloma Virus 18
vaccine
Cervical Intraepithelial Neoplasia
cervical Cancer

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 24, 2014