Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent(Type 16/18 )Vaccine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Jun Zhang, Xiamen University
ClinicalTrials.gov Identifier:
NCT01735006
First received: November 18, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18 years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference of safety and immunogenicity among different lots. Approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV) vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a 0-1-6 month schedule.


Condition Intervention Phase
Cervical Intraepithelial Neoplasia
Cervical Cancer
Vaginal Intraepithelial Neoplasia
Vulvar Intraepithelial Neoplasia
Persistent Infection
Biological: HPV Vaccine
Biological: HEV vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III Multicenter, Randomized, Double-Blind, Placebo(Hepatitis E Vaccine)Controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant(E.Coli)Human Papillomavirus Bivalent Vaccine in Healthy Women

Resource links provided by NLM:


Further study details as provided by Xiamen University:

Primary Outcome Measures:
  • Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection [ Time Frame: expected 5-6 years ] [ Designated as safety issue: No ]
  • Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) [ Time Frame: expected 2-3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: Within 7 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Month 7 ] [ Designated as safety issue: Yes ]
  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: expected 5-6 years ] [ Designated as safety issue: Yes ]
  • number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18 [ Time Frame: expected 5-6 years ] [ Designated as safety issue: No ]
  • number of subjects Histopathologically-confirmed CIN1+ and/or VIN1+ and/or VaIN1+ associated with HPV-16 and/or -18 cervical infection [ Time Frame: expected 5-6 years ] [ Designated as safety issue: No ]
  • number of subjects with incidence infection associated with HPV-16 and/or HPV-18 [ Time Frame: expected 2-3 years ] [ Designated as safety issue: No ]
  • Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 [ Time Frame: month 7 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of subjects histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types [ Time Frame: expected 5-6 years ] [ Designated as safety issue: No ]
    Histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types (e.g. HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) detected within the lesional component of the tissue specimen (by PCR).


Estimated Enrollment: 6000
Study Start Date: November 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPV vaccine
This dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant
Biological: HPV Vaccine
3 doses at month 0,1 and 6
Placebo Comparator: HEV vaccine
commercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant
Biological: HEV vaccine
3 doses at month 0,1 and 6
Other Name: Hecolin

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female subjects between, and including, 18 and 45 years of age at the first vaccination;
  2. Healthy subjects as established by medical history and history-oriented clinical examination;
  3. Be able to understand and comply with the request of the protocol;
  4. Without acute cervicitis;
  5. Not pregnant;
  6. Have intact cervix.

Exclusion Criteria:

  1. Use of any investigational or non-registered product (drug or vaccine)within 30 days preceding the first vaccination, or plan to use during the study period;
  2. Are using immunosuppressants;
  3. Administration of immunoglobulin and/or any blood products within the three months preceding the first vaccination or planned administration during the study period;
  4. Vaccinated of inactivated vaccine 14 days or attenuated vaccine 21 days before the enrollment;
  5. Fever;
  6. Concurrently participating another clinical trial;
  7. Has received vaccines against HPV 16/18 ;
  8. Immunodeficient;
  9. History of allergic disease;
  10. Serious medical disorders;
  11. Blood coagulation disorders;
  12. Epilepsy;
  13. Unable to comply with protocol due to the mental illness;
  14. Visible Condyloma;
  15. Pregnant or breast-feeding women;
  16. vergins;
  17. Have more than 4 sexual partners.
  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: NCT01735006

Locations
China
Cancer Institute & Hospital Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Xiamen University
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Ministry of Science and Technology of the People´s Republic of China
Investigators
Study Chair: Jun Zhang, Master Xiamen University
Principal Investigator: Youlin Qiao, Ph.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Director: Ting Wu, Ph. D Xiamen University
  More Information

No publications provided

Responsible Party: Jun Zhang, professor, Xiamen University
ClinicalTrials.gov Identifier: NCT01735006     History of Changes
Other Study ID Numbers: HPV-PRO-003
Study First Received: November 18, 2012
Last Updated: July 8, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xiamen University:
Human Papillomavirus 16
Human Papillomavirus 18
vaccine
Cervical Intraepithelial Neoplasia
cervical Cancer
Vaginal intraepithelial neoplasia
Vulvar intraepithelial neoplasia

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
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 September 16, 2014