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

February 21, 2020 updated by: Jun Zhang, Xiamen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7372

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Cancer Institute & Hospital Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Hecolin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
expected 2-3 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
expected 5-6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiamen University

Collaborators

Ministry of Science and Technology of the People´s Republic of China
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Investigators

  • Principal Investigator: Youlin Qiao, Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Study Director: Ting Wu, Ph. D, Xiamen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2012

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

October 18, 2019

Study Registration Dates

First Submitted

November 18, 2012

First Submitted That Met QC Criteria

November 23, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV-PRO-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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