Cervical Intraepithelial NeoplasiaNCT06243666
Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls
An observational study of Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Xiamen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Cervical Cancer, Persistent Infection
- What is being tested?
- Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)
- Type of treatment
- Vaccines
- How many people
- 2,188 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sheyang County Center for Disease Control and Prevention
Yancheng, Jiangsu
About this study
Official title: 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.
Read the 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.
- Being tested
- Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli), No intervention
- Keywords
- Human Papilloma Virus 16, Human Papilloma Virus 18, Adolescent girl, Long-term Effectiveness, Immuno-persistence
- 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.
Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)Biological
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.
No interventionOther
No intervention was implemented.
Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) | |
| 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. Receives: Other: No intervention | |
| 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. Receives: Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 16 and 18
To evaluate the efficacy of the bivalent vaccine against this outcome
Measured: 8-10 years after the first dose
Anti-HPV 16 and 18 IgG antibody seropositive rates and geometric mean concentrations
To detect the anti-HPV 16 and anti-HPV 18 type-specific IgG antibody level 9 years after the first dose
Measured: 9 years after the first dose
Secondary outcomes (1)
Incidence of persistent infection, transient infection, and cervical precancerous CIN1+ lesions associated with HPV types 31/33/45
To evaluate the efficacy of the bivalent vaccine against this outcome
Measured: 8-10 years after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start20 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Center for Disease Control and Prevention, Sheyang County, Yancheng City, Jiangsu Province, China
- Responsible party
- Principal investigator, Jun Zhang, Xiamen University
- Investigators
- Ting Wu, Ph. D., Principal investigator, Xiamen UniversityJun Zhang, MSc, Study chair, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243666
- Sponsor's protocol ID
- HPV-PRO-006-4
- Status last verified
- Jul 2025
- First submitted
- 29 Jan 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effectiveness and Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Girls Aged 9-17 Years
- ClinicalTrials.gov ID
- NCT06243666
- Acronym / sponsor ID
- HPV-PRO-006-4
- Keywords
- Human Papilloma Virus 16, Human Papilloma Virus 18, Adolescent girl, Long-term Effectiveness, Immuno-persistence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,188 participants (estimated)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Center for Disease Control and Prevention, Sheyang County, Yancheng City, Jiangsu Province, China
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccine group for long-term effectiveness evaluation | – | Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)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. |
| Control group for long-term effectiveness evaluation | – | Other: No interventionNo intervention was implemented in this study. Participants with no previous HPV vaccination history were recruited as the control group for long-term effectiveness evaluation. |
| Vaccine group for immuno-persistence evaluation | – | Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Vaccine group for long-term effectiveness evaluation |
| No interventionNo intervention was implemented. | Other | Control group for long-term effectiveness evaluation |
| 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. | Biological | Vaccine group for immuno-persistence evaluation |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Wu, Ph. D. principal investigator
Xiamen University
Jun Zhang, MSc study chair
Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
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). 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?
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 31 Jul 2025.