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Cervical Intraepithelial NeoplasiaPhase 3NCT01735006

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

A Phase 3 study testing HPV Vaccine and HEV vaccine in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Xiamen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
HPV Vaccine and HEV vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7,372 participants
Where
1 siteChina
Study dates
22 Nov 2012to 18 Oct 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Institute ＆ Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

Other trials in China

About this study

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

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.

Being tested
HPV Vaccine, HEV vaccine
Keywords
Human Papillomavirus 16, Human Papillomavirus 18, vaccine, Cervical Intraepithelial Neoplasia, cervical Cancer, Vaginal intraepithelial neoplasia, Vulvar intraepithelial neoplasia
Medical subject headings
Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Persistent Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPV VaccineBiological

    3 doses at month 0,1 and 6

  • HEV vaccineBiological

    Also called Hecolin

    3 doses at month 0,1 and 6

Study groups in NCT01735006
Study groupRoleWhat they receive
HPV vaccineExperimentalThis dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant
Receives: Biological: HPV Vaccine
HEV vaccinePlacebo comparatorcommercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant
Receives: Biological: HEV vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: expected 5-6 years

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

    Measured: expected 2-3 years

Secondary outcomes (7)

  1. Number of Subjects Reporting Solicited Local and General Symptoms

    Measured: Within 7 days after each vaccination

  2. Number of Subjects Reporting Unsolicited Adverse Events

    Measured: Month 7

  3. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Measured: expected 5-6 years

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

    Measured: 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

    Measured: expected 5-6 years

  6. number of subjects with incidence infection associated with HPV-16 and/or HPV-18

    Measured: expected 2-3 years

  7. Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7

    Measured: month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2012 (estimated)
  2. Study start22 Nov 2012
  3. Primary completion1 Aug 2019
  4. Study completion18 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
7,372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01735006
Sponsor's protocol ID
HPV-PRO-003
Status last verified
Feb 2020
First submitted
18 Nov 2012
Last updated
24 Feb 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Quan J, Chen Q, Lan L, Zhang B, Hu Y, Zhao F, Wang X, Wang X, Huang J, Zhong G, Bi Z, Su Y, Huang S, Wei L, Zhao F, Zhang J, Wu T, Xia N. Type- and age-specific natural history of high-risk human papillomavirus infections in healthy women: A prospective cohort study in China. Int J Cancer. 2026 May 15;158(10):2736-2746. doi: 10.1002/ijc.70337. Epub 2026 Jan 16.

    PubMed 41544035

  • 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;11(1):16. doi: 10.1038/s41541-025-01335-2.

    PubMed 41407728

  • Chen Q, Yao X, Quan J, Jia X, Li Y, Zhu K, Hu X, Huang X, Zhong G, Qiu L, Bi Z, Liao M, Chen L, Kuang X, Wang Z, Hu S, Zhuang C, Huang S, Wei L, Chen W, Su Y, Zhao F, Wu T, Qiao Y, Zhang J, Xia N. The variations in the natural history of high-risk human papillomavirus infections in Chinese healthy women aged 27-45 years compared with 18-26 years: A prospective cohort study. Int J Cancer. 2025 Mar 1;156(5):1043-1054. doi: 10.1002/ijc.35290. Epub 2024 Dec 13.

    PubMed 39670565

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HPV Vaccine and HEV vaccine in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Xiamen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01735006, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.

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