CClinicalTrials.gg
Sign In
CompletedNCT01735006Updated Feb 24, 2020

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

A Phase 3 interventional study of HPV Vaccine and HEV vaccine in Cervical Intraepithelial Neoplasia, Cervical Cancer and Vaginal Intraepithelial Neoplasia, sponsored by Xiamen University. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-24.

Sponsored by Xiamen University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
7,372
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
7,372 participants (actual)

Study arms

  • 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

  • Placebo comparator
    HEV vaccine

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

    Biological: HEV vaccine

Interventions

  • BiologicalHPV Vaccine

    3 doses at month 0,1 and 6

  • BiologicalHEV vaccine

    3 doses at month 0,1 and 6

    Also known as: Hecolin

05

What researchers measure

Primary outcomes

  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 outcomes

  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 outcomes

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

    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

06

Study locations

1 site
  • Cancer Institute ＆ Hospital Chinese Academy of Medical Sciences
    Beijing, 100021, China
07

References and documents

Publications

  • 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. PubMed 36037823 ↗
08

Registry details

Key details

Study ID
NCT01735006
Lead 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
Responsible party
Jun Zhang (professor, Xiamen University) — Principal investigator
First posted
Nov 28, 2012
Start date
Nov 22, 2012
Primary completion
Aug 1, 2019
Completion
Oct 18, 2019
Last update
Feb 24, 2020

Study contacts

Jun Zhang, Master
study chair · Xiamen University
Youlin Qiao, Ph.D
principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Ting Wu, Ph. D
study director · Xiamen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Persistent Infection→

Other studies from this sponsor

Xiamen University

Start the discussion