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: June 27, 2017

Last verified: June 2017

History of Changes

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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:

Drug Information available for: Human Papillomaviruses

Genetic and Rare Diseases Information Center resources: Cervical Intraepithelial Neoplasia Hepatitis E

U.S. FDA Resources

Further study details as provided by Jun Zhang, 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 ]
Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) [ Time Frame: expected 2-3 years ]

Secondary Outcome Measures:

Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: Within 7 days after each vaccination ]
Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Month 7 ]
Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: expected 5-6 years ]
number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18 [ Time Frame: expected 5-6 years ]
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 ]
number of subjects with incidence infection associated with HPV-16 and/or HPV-18 [ Time Frame: expected 2-3 years ]
Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 [ Time Frame: month 7 ]

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 ]
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:	December 2017 (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 (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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;
Are using immunosuppressants;
Administration of immunoglobulin and/or any blood products within the three months preceding the first vaccination or planned administration during the study period;
Vaccinated of inactivated vaccine 14 days or attenuated vaccine 21 days before the enrollment;
Fever;
Concurrently participating another clinical trial;
Has received vaccines against HPV 16/18 ;
Immunodeficient;
History of allergic disease;
Serious medical disorders;
Blood coagulation disorders;
Epilepsy;
Unable to comply with protocol due to the mental illness;
Visible Condyloma;
Pregnant or breast-feeding women;
vergins;
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


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:	June 27, 2017

Keywords provided by Jun Zhang, 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 Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 20, 2017

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