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
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
-
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Jiangsu
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Yancheng, Jiangsu, China
- Sheyang County Center for Disease Control and Prevention
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-
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.
|
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.
|
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.
|
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
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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
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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
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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
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8-10 years after the first dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Disease Attributes
- Infections
- Uterine Diseases
- Genital Diseases, Female
- Precancerous Conditions
- Uterine Cervical Diseases
- Persistent Infection
- Uterine Cervical Dysplasia
- Immunologic Factors
- Physiological Effects of Drugs
- Vaccines
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
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