Human Papillomavirus InfectionNCT07833852
Long-Term Immune Persistence After Bivalent HPV Vaccination in Females From Study 311-HPV-1005
An observational study of Human Papillomavirus Infection and Cervical Intraepithelial Neoplasia, run by Shanghai Zerun Biotechnology Co.,Ltd at 1 site in China.
Trial summary
This is a single-center, open-label, prospective observational extension of Study 311-HPV-1005 (NCT04965350). The study follows females who received at least one dose of a bivalent human papillomavirus vaccine containing HPV-16 and HPV-18 L1 virus-like particles in the base study. Read more about this study
- Who is it for?
- Ages 12 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia
- What is being tested?
- Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 486 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2024to Dec 2027
- 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 12 to 34 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Females previously enrolled in the single-center base study 311-HPV-1005 (NCT04965350) at the Mianyang Center for Disease Control and Prevention. The immunogenicity persistence subset comprises participants who completed the three-dose vaccination schedule and had valid neutralizing antibody results at baseline and Month 7. The breakthrough-case cohort comprises participants who received at least one dose of the study vaccine and were at least 18 years of age at extension-study enrollment or became 18 years of age during the extension study.
Who may be able to join
- Previously enrolled in Study 311-HPV-1005 (NCT04965350) at the Mianyang Center for Disease Control and Prevention.
- Received at least one dose of the bivalent HPV vaccine in the base study.
- For the immunogenicity persistence subset: completed all three doses in the base study and had valid neutralizing antibody results before vaccination and one month after the third dose.
- For the breakthrough-case cohort: at least 18 years of age at extension-study enrollment or becoming 18 years of age during the extension study.
- Participant provided written informed consent; for a participant younger than 18 years at extension-study enrollment, the participant and at least one parent or legal guardian provided written informed consent or assent as required.
- Able to understand and comply with the study procedures. Participants in the immunogenicity persistence subset agreed to blood collection at Months 42 and 66. Participants in the breakthrough-case cohort agreed to scheduled remote or site follow-up and to provide relevant HPV- and cervical-disease information.
Who cannot join
- Receipt of any other HPV vaccine during Study 311-HPV-1005 or between completion of the base study and enrollment in this extension.
- At a visit involving blood collection, any condition that may interfere with venipuncture, including a platelet count below 20 x 10^9/L, phlebitis, or hemophilia.
- Any other factor that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Mianyang Center for Disease Control and Prevention
Mianyang, Sichuan
About this study
Official title: A Single-Center, Open-Label, Long-Term Extension Study to Evaluate Immune Persistence Following Vaccination With a Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) in Healthy Females Aged 9 to 30 Years at Enrollment in Study 311-HPV-1005
This is a single-center, open-label, prospective observational extension of Study 311-HPV-1005 (NCT04965350). The study follows females who received at least one dose of a bivalent human papillomavirus vaccine containing HPV-16 and HPV-18 L1 virus-like particles in the base study. No vaccine is administered in this extension. Participants in the immunogenicity persistence subset provide blood samples at Months 42 and 66 after the first dose in the base study for measurement of HPV-16 and HPV-18 neutralizing antibodies. Participants eligible for the breakthrough-case cohort are followed for HPV-related cervical disease, including HPV-16- or HPV-18-related cervical intraepithelial neoplasia grade 2 or worse.
- Being tested
- Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)
- Keywords
- Bivalent HPV vaccine, immune persistence, neutralizing antibody, long-term follow-up, breakthrough case, CIN2+, Pichia pastoris
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Dysplasia
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 and 18) Vaccine (Pichia pastoris)Biological
Historical exposure assigned in the base study: three intramuscular 0.5-mL doses at Months 0, 2, and 6.
Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)Biological
Historical exposure assigned in the base study: three intramuscular 0.5-mL doses at Months 0, 2, and 6.
| Study group | Role | What they receive |
|---|---|---|
| Commercial-Scale Vaccine Cohort | Participants who were assigned in NCT04965350 to receive one of three consecutive commercial-scale lots of the bivalent HPV vaccine on a 0-, 2-, and 6-month schedule. No vaccine is administered in the extension study. Receives: Biological: Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris) | |
| Clinical-Scale Vaccine Cohort | Participants who were assigned in NCT04965350 to receive the clinical-scale lot of the bivalent HPV vaccine on a 0-, 2-, and 6-month schedule. No vaccine is administered in the extension study. Receives: Biological: Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer of Neutralizing Antibodies Against HPV-16
Serum HPV-16 neutralizing antibody titers are measured using a high-throughput pseudovirus-based neutralization assay. The geometric mean titer and 95% confidence interval are summarized overall and by exposure cohort at each time point.
Measured: At Months 42 and 66 after the first dose in the base study
Geometric Mean Titer of Neutralizing Antibodies Against HPV-18
Serum HPV-18 neutralizing antibody titers are measured using a high-throughput pseudovirus-based neutralization assay. The geometric mean titer and 95% confidence interval are summarized overall and by exposure cohort at each time point.
Measured: At Months 42 and 66 after the first dose in the base study
Percentage of Participants Seropositive for Neutralizing Antibodies Against HPV-16
The percentage of participants with an HPV-16 neutralizing antibody titer at or above the assay cutoff specified in the statistical analysis plan is summarized with an exact 95% confidence interval at each time point.
Measured: At Months 42 and 66 after the first dose in the base study
Percentage of Participants Seropositive for Neutralizing Antibodies Against HPV-18
The percentage of participants with an HPV-18 neutralizing antibody titer at or above the assay cutoff specified in the statistical analysis plan is summarized with an exact 95% confidence interval at each time point.
Measured: At Months 42 and 66 after the first dose in the base study
Secondary outcomes (1)
Number and Percentage of Participants With HPV-16- and/or HPV-18-Related CIN2+ Breakthrough Cases
A breakthrough case is defined as cervical histopathology showing CIN2, CIN3, adenocarcinoma in situ, or cervical cancer, with HPV DNA testing of the cervical tissue positive for HPV-16 and/or HPV-18. The number and percentage of participants with a breakthrough case are summarized overall and by exposure cohort.
Measured: From the first dose in the base study through Month 66 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 posted22 Sep 2026
- Study start30 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies 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
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yuxi Zerun Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833852
- Sponsor's protocol ID
- 311-HPV-1005-EXTEND
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned for public sharing.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Long-Term Extension Study to Evaluate Immune Persistence Following Vaccination With a Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) in Healthy Females Aged 9 to 30 Years at Enrollment in Study 311-HPV-1005
- ClinicalTrials.gov ID
- NCT07833852
- Acronym / sponsor ID
- 311-HPV-1005-EXTEND
- Keywords
- Bivalent HPV vaccine, immune persistence, neutralizing antibody, long-term follow-up, breakthrough case, CIN2+, Pichia pastoris
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Yuxi Zerun Biotechnology Co., Ltd.
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Sep 2026 (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.
This is a single-center, open-label, prospective observational extension of Study 311-HPV-1005 (NCT04965350). The study follows females who received at least one dose of a bivalent human papillomavirus vaccine containing HPV-16 and HPV-18 L1 virus-like particles in the base study. No vaccine is administered in this extension. Participants in the immunogenicity persistence subset provide blood samples at Months 42 and 66 after the first dose in the base study for measurement of HPV-16 and HPV-18 neutralizing antibodies. Participants eligible for the breakthrough-case cohort are followed for HPV-related cervical disease, including HPV-16- or HPV-18-related cervical intraepithelial neoplasia grade 2 or worse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercial-Scale Vaccine Cohort | – | Biological: Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)Participants who were assigned in NCT04965350 to receive one of three consecutive commercial-scale lots of the bivalent HPV vaccine on a 0-, 2-, and 6-month schedule. No vaccine is administered in the extension study. |
| Clinical-Scale Vaccine Cohort | – | Biological: Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)Participants who were assigned in NCT04965350 to receive the clinical-scale lot of the bivalent HPV vaccine on a 0-, 2-, and 6-month schedule. No vaccine is administered in the extension study. |
Who may qualify
- Ages
- 12 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Females previously enrolled in the single-center base study 311-HPV-1005 (NCT04965350) at the Mianyang Center for Disease Control and Prevention. The immunogenicity persistence subset comprises participants who completed the three-dose vaccination schedule and had valid neutralizing antibody results at baseline and Month 7. The breakthrough-case cohort comprises participants who received at least one dose of the study vaccine and were at least 18 years of age at extension-study enrollment or became 18 years of age during the extension study.
Key inclusion criteria (6 listed)
- Previously enrolled in Study 311-HPV-1005 (NCT04965350) at the Mianyang Center for Disease Control and Prevention.
- Received at least one dose of the bivalent HPV vaccine in the base study.
- For the immunogenicity persistence subset: completed all three doses in the base study and had valid neutralizing antibody results before vaccination and one month after the third dose.
- For the breakthrough-case cohort: at least 18 years of age at extension-study enrollment or becoming 18 years of age during the extension study.
- Participant provided written informed consent; for a participant younger than 18 years at extension-study enrollment, the participant and at least one parent or legal guardian provided written informed consent or assent as required.
Key exclusion criteria (3 listed)
- Receipt of any other HPV vaccine during Study 311-HPV-1005 or between completion of the base study and enrollment in this extension.
- At a visit involving blood collection, any condition that may interfere with venipuncture, including a platelet count below 20 x 10^9/L, phlebitis, or hemophilia.
- Any other factor that, in the investigator's judgment, makes the participant unsuitable for 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 and 18) Vaccine (Pichia pastoris)Historical exposure assigned in the base study: three intramuscular 0.5-mL doses at Months 0, 2, and 6. | Biological | Commercial-Scale Vaccine Cohort |
| Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)Historical exposure assigned in the base study: three intramuscular 0.5-mL doses at Months 0, 2, and 6. | Biological | Clinical-Scale Vaccine Cohort |
Primary outcome
Geometric Mean Titer of Neutralizing Antibodies Against HPV-16
Time frame: At Months 42 and 66 after the first dose in the base study
Serum HPV-16 neutralizing antibody titers are measured using a high-throughput pseudovirus-based neutralization assay. The geometric mean titer and 95% confidence interval are summarized overall and by exposure cohort at each time point.
Geometric Mean Titer of Neutralizing Antibodies Against HPV-18
Time frame: At Months 42 and 66 after the first dose in the base study
Serum HPV-18 neutralizing antibody titers are measured using a high-throughput pseudovirus-based neutralization assay. The geometric mean titer and 95% confidence interval are summarized overall and by exposure cohort at each time point.
Percentage of Participants Seropositive for Neutralizing Antibodies Against HPV-16
Time frame: At Months 42 and 66 after the first dose in the base study
The percentage of participants with an HPV-16 neutralizing antibody titer at or above the assay cutoff specified in the statistical analysis plan is summarized with an exact 95% confidence interval at each time point.
Percentage of Participants Seropositive for Neutralizing Antibodies Against HPV-18
Time frame: At Months 42 and 66 after the first dose in the base study
The percentage of participants with an HPV-18 neutralizing antibody titer at or above the assay cutoff specified in the statistical analysis plan is summarized with an exact 95% confidence interval at each time point.
1 secondary outcome
Number and Percentage of Participants With HPV-16- and/or HPV-18-Related CIN2+ Breakthrough Cases
Time frame: From the first dose in the base study through Month 66 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 22 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data are not planned for public sharing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Human Papillomavirus Infection and Cervical Intraepithelial Neoplasia, run by Shanghai Zerun Biotechnology Co.,Ltd 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 3 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: enrolling by invitation, as of the sponsor's last update on 22 Sep 2026. 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?
Geometric Mean Titer of Neutralizing Antibodies Against HPV-16 (time frame: At Months 42 and 66 after the first dose in the base study). The study lists 4 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 22 Sep 2026.