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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection	Biological: HPV Vaccine; Biological: HEV vaccine	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	6000 participants
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
Study Start Date :	November 2012
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	September 2018

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
2. Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) [ Time Frame: expected 2-3 years ]

Secondary Outcome Measures :

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

Other Outcome Measures:

1. 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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes 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

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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

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Responsible Party:	Jun Zhang, professor, Xiamen University
ClinicalTrials.gov Identifier:	NCT01735006 History of Changes
Other Study ID Numbers:	HPV-PRO-003
First Posted:	November 28, 2012
Last Update Posted:	June 29, 2017
Last Verified:	June 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