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

Primary Purpose

Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HPV Vaccine
HEV vaccine
Sponsored by
Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Intraepithelial Neoplasia focused on measuring Human Papillomavirus 16, Human Papillomavirus 18, vaccine, Cervical Intraepithelial Neoplasia, cervical Cancer, Vaginal intraepithelial neoplasia, Vulvar intraepithelial neoplasia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Cancer Institute ＆ Hospital Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HPV vaccine

HEV vaccine

Arm Description

This dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant

commercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant

Outcomes

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
Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition)

Secondary Outcome Measures

Number of Subjects Reporting Solicited Local and General Symptoms
Number of Subjects Reporting Unsolicited Adverse Events
Number of Subjects Reporting Serious Adverse Events (SAEs)
number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18
number of subjects Histopathologically-confirmed CIN1+ and/or VIN1+ and/or VaIN1+ associated with HPV-16 and/or -18 cervical infection
number of subjects with incidence infection associated with HPV-16 and/or HPV-18
Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7

Full Information

First Posted
November 18, 2012
Last Updated
February 21, 2020
Sponsor
Xiamen University
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
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1. Study Identification

Unique Protocol Identification Number
NCT01735006
Brief Title
Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine
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 Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 22, 2012 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
October 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xiamen University
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Persistent Infection
Keywords
Human Papillomavirus 16, Human Papillomavirus 18, vaccine, Cervical Intraepithelial Neoplasia, cervical Cancer, Vaginal intraepithelial neoplasia, Vulvar intraepithelial neoplasia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HPV vaccine
Arm Type
Experimental
Arm Description
This dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant
Arm Title
HEV vaccine
Arm Type
Placebo Comparator
Arm Description
commercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant
Intervention Type
Biological
Intervention Name(s)
HPV Vaccine
Intervention Description
3 doses at month 0,1 and 6
Intervention Type
Biological
Intervention Name(s)
HEV vaccine
Other Intervention Name(s)
Hecolin
Intervention Description
3 doses at month 0,1 and 6
Primary Outcome Measure Information:
Title
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
Title
Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition)
Time Frame
expected 2-3 years
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting Solicited Local and General Symptoms
Time Frame
Within 7 days after each vaccination
Title
Number of Subjects Reporting Unsolicited Adverse Events
Time Frame
Month 7
Title
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame
expected 5-6 years
Title
number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18
Time Frame
expected 5-6 years
Title
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
Title
number of subjects with incidence infection associated with HPV-16 and/or HPV-18
Time Frame
expected 2-3 years
Title
Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7
Time Frame
month 7
Other Pre-specified Outcome Measures:
Title
Number of subjects histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types
Description
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).
Time Frame
expected 5-6 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, Master
Organizational Affiliation
Xiamen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Youlin Qiao, Ph.D
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ting Wu, Ph. D
Organizational Affiliation
Xiamen University
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Institute ＆ Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36037823
Citation
Zhao FH, Wu T, Hu YM, Wei LH, Li MQ, Huang WJ, Chen W, Huang SJ, Pan QJ, Zhang X, Hong Y, Zhao C, Li Q, Chu K, Jiang YF, Li MZ, Tang J, Li CH, Guo DP, Ke LD, Wu X, Yao XM, Nie JH, Lin BZ, Zhao YQ, Guo M, Zhao J, Zheng FZ, Xu XQ, Su YY, Zhang QF, Sun G, Zhu FC, Li SW, Li YM, Pan HR, Zhang J, Qiao YL, Xia NS. Efficacy, safety, and immunogenicity of an Escherichia coli-produced Human Papillomavirus (16 and 18) L1 virus-like-particle vaccine: end-of-study analysis of a phase 3, double-blind, randomised, controlled trial. Lancet Infect Dis. 2022 Dec;22(12):1756-1768. doi: 10.1016/S1473-3099(22)00435-2. Epub 2022 Aug 26.
Results Reference
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Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine

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