Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls

July 28, 2025 updated by: Jun Zhang, Xiamen University

Long-term Effectiveness and Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Girls Aged 9-17 Years

The primary objective of this study is to evaluate the protective efficacy against future infections of HPV types 16/18 or related diseases and immuno-persistence (type specific IgG antibody) of the bivalent HPV vaccine in young female populations aged 9-17 years.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a follow-up study that is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) . This study proposes to conduct a prospective cohort study based on the cohort population from the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) . By matching control groups according to factors such as age and education level, and through long-term follow-up, this research aims to elucidate the protective efficacy of the bivalent HPV vaccine against future infections of HPV types 16/18/31/33/45 or related diseases in young female populations aged 9-17 years. Additionally, the study will evaluate the persistence of vaccine-induced antibodies, investigate the potential for type replacement/competition phenomena post-vaccination and assess oral HPV infections in the cohort population.

Study Type

Observational

Enrollment (Estimated)

2188

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
    • Jiangsu
      • Yancheng, Jiangsu, China
        • Sheyang County Center for Disease Control and Prevention

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants who participated in the bridging study (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508) and received at least one dose will be recruited as vaccine group. Participants with no previous HPV vaccination history were recruited as the control group.

Description

Inclusion Criteria:

  • Participants must be at least 18 years old;
  • Participants who have participated in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) and have received at least one dose of the vaccine (only applicable to the vaccine group);
  • Able to understand the study procedure and have the ability to comply with the protocol requirements (e.g., collection of biological samples and regular follow-up) and sign a written informed consent form;

Exclusion Criteria:

  • Participants who did not experience sexual debut;*
  • Participants with acute cervical inflammation and acute lower genital tract infection;*
  • Participants during menstruation, or have vaginal medication, sexual behavior within two days (48 hours) before the visit, which may affect gynecological examinations and specimens collection;*
  • Participants in the vaccine group have used other HPV vaccine products (including both marketed and unmarketed vaccines) after participating in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508); Participants in the control group have used HPV vaccine products (including both marketed and unmarketed vaccines);

  • According to the judgement of investigator, various medical, psychological, social, vocational or other factors that are not suitable for participating in the study.

    • Note: For criteria marked with an asterisk (*), if the participant meets that exclusion criterion, it does not affect the blood sample collection.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccine group for long-term effectiveness evaluation
No intervention was implemented in this study. Participants who have participated in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) and were aged 9-17 years at the time of enrollment, and have received at least one dose of the vaccine were recruited as the vaccine group for long-term effectiveness evaluation.
Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)
The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant.
Control group for long-term effectiveness evaluation
No intervention was implemented in this study. Participants with no previous HPV vaccination history were recruited as the control group for long-term effectiveness evaluation.
Other: No intervention
No intervention was implemented.
Vaccine group for immuno-persistence evaluation
No intervention was implemented in this study. Participants who have participated in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) and were aged 9-26 years at the time of enrollment, and have received at least one dose of the vaccine were recruited as the vaccine group for immuno-persistence evaluation.
Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)
The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 16 and 18
Time Frame: 8-10 years after the first dose
To evaluate the efficacy of the bivalent vaccine against this outcome
8-10 years after the first dose
Anti-HPV 16 and 18 IgG antibody seropositive rates and geometric mean concentrations
Time Frame: 9 years after the first dose
To detect the anti-HPV 16 and anti-HPV 18 type-specific IgG antibody level 9 years after the first dose
9 years after the first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 31/33/45
Time Frame: 8-10 years after the first dose
To evaluate the efficacy of the bivalent vaccine against this outcome
8-10 years after the first dose

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of persistent infections, transient infections, and CIN1+ lesions associated with other high-risk types (except HPV types 16, 18, 31, 33, and 45).
Time Frame: 8-10 years after the first dose
To investigate the potential for type replacement/competition phenomena post-vaccination
8-10 years after the first dose
Incidence of transient and persistent infections with oral HPV
Time Frame: 8-10 years after the first dose
To explore the incidence of transient and persistent oral HPV infections in vaccinated and unvaccinated populations
8-10 years after the first dose

Collaborators and Investigators

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

Sponsor

Xiamen University

Collaborators

Xiamen Innovax Biotech Co., Ltd
Center for Disease Control and Prevention, Sheyang County, Yancheng City, Jiangsu Province, China

Investigators

  • Principal Investigator: Ting Wu, Ph. D., Xiamen University
  • Study Chair: Jun Zhang, MSc, Xiamen University

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)

February 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV-PRO-006-4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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