NCT01735006

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,372

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

November 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2019

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

6.7 years

First QC Date

November 18, 2012

Last Update Submit

February 21, 2020

Conditions

Cervical Intraepithelial NeoplasiaCervical CancerVaginal Intraepithelial NeoplasiaVulvar Intraepithelial NeoplasiaPersistent Infection

Keywords

Human Papillomavirus 16Human Papillomavirus 18vaccineCervical Intraepithelial Neoplasiacervical CancerVaginal intraepithelial neoplasiaVulvar intraepithelial neoplasia

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection

    expected 5-6 years

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

    expected 2-3 years

Secondary Outcomes (7)

  • Number of Subjects Reporting Solicited Local and General Symptoms

    Within 7 days after each vaccination

  • Number of Subjects Reporting Unsolicited Adverse Events

    Month 7

  • Number of Subjects Reporting Serious Adverse Events (SAEs)

    expected 5-6 years

  • number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18

    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

    expected 5-6 years

  • +2 more secondary outcomes

Other Outcomes (1)

  • Number of subjects histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types

    expected 5-6 years

Study Arms (2)

HPV vaccine

EXPERIMENTAL

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

HEV vaccine

PLACEBO COMPARATOR

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

Biological: HEV vaccine

Interventions

HPV VaccineBIOLOGICAL

3 doses at month 0,1 and 6

HPV vaccine
HEV vaccineBIOLOGICAL

3 doses at month 0,1 and 6

Also known as: Hecolin
HEV vaccine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute ＆ Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (2)

  • Liao M, Quan J, Zhu K, Hu X, Shen S, Xu J, Nie C, Xu W, Jiang H, Wu X, Zhong Y, Peng Y, Cai S, Chen J, Zhang C, Lin B, Su Y, Huang S, Chen Q, Wu T, Zhang J, Xia N. Immunopersistence of one or two doses of an Escherichia coli produced bivalent HPV vaccine. NPJ Vaccines. 2025 Dec 17. doi: 10.1038/s41541-025-01335-2. Online ahead of print.

    PMID: 41407728DERIVED

  • 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.

    PMID: 36037823DERIVED

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical NeoplasmsPersistent Infection

Interventions

Papillomavirus Vaccineshecolin

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Jun Zhang, Master

    Xiamen University

    STUDY CHAIR

  • Youlin Qiao, Ph.D

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Ting Wu, Ph. D

    Xiamen University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 18, 2012

First Posted

November 28, 2012

Study Start

November 22, 2012

Primary Completion

August 1, 2019

Study Completion

October 18, 2019

Last Updated

February 24, 2020

Record last verified: 2020-02

Locations

CN(1)