Human Papillomavirus InfectionNCT07820241
Long-term Immune Persistence of a Bivalent HPV Vaccine in Females From Study 311-HPV-1004
An observational study of Human Papillomavirus Infection, run by Shanghai Zerun Biotechnology Co.,Ltd at 2 sites in China.
Trial summary
This long-term extension study evaluates the persistence of neutralizing antibody responses to a bivalent human papillomavirus vaccine in females who previously participated in study 311-HPV-1004 (NCT02740777). Read more about this study
- Who is it for?
- Ages 16 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)
- Type of treatment
- Vaccines
- How many people
- 348 participants
- Where
- 2 sitesChina
- Study dates
- 25 Mar 2023to 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 16 to 34 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Females previously enrolled in study 311-HPV-1004 (NCT02740777) at the Hezhou and Zhongshan study sites in Guangxi, China, who completed the required blood-collection visits in the base study and met the eligibility criteria for the extension study.
Who may be able to join
- The participant, and the participant's legal guardian when applicable, is able to understand the study information and voluntarily sign the informed consent form for the extension study.
- In the investigator's judgment, the participant is able to comply with protocol requirements, including attending scheduled visits and responding to follow-up telephone contacts.
- The participant was enrolled in study 311-HPV-1004 and completed blood collection at Day 0 and Months 7, 12, 24, and 36.
Who cannot join
- Receipt of any HPV vaccine other than the study vaccine during study 311-HPV-1004 or between completion of that study and enrollment in this extension study.
- Use of an investigational or unregistered product, other than the study vaccine, during study 311-HPV-1004 or between completion of that study and enrollment in this extension study.
- Seropositivity for both HPV-16 and HPV-18 antibodies at baseline in study 311-HPV-1004.
- Long-term use of immunosuppressive agents or
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hezhou Center for Disease Control and Prevention
Hezhou, Guangxi
Zhongshan County Center for Disease Control and Prevention
Hezhou, Guangxi
About this study
Official title: An Open-label, Long-term Extension Study to Evaluate the Persistence of Immune Responses to a Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) in Healthy Females Who Were Aged 9 to 26 Years at Enrollment in Study 311-HPV-1004
This long-term extension study evaluates the persistence of neutralizing antibody responses to a bivalent human papillomavirus vaccine in females who previously participated in study 311-HPV-1004 (NCT02740777). Participants belonged to one of three vaccination cohorts in the base study: adolescents who received two doses at Months 0 and 6, adolescents who received three doses at Months 0, 2, and 6, and adults who received three doses at Months 0, 2, and 6. No vaccine is administered in the extension study. Blood samples are collected at Months 84, 108, and 132 after the first dose in the base study and tested for HPV-16 and HPV-18 neutralizing antibodies using a high-throughput pseudovirus-based neutralization assay.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)
- Keywords
- Bivalent HPV vaccine, Immune persistence, Neutralizing antibody, Two-dose vaccination schedule, Long-term follow-up, Pichia pastoris
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)Biological
Each 0.5 mL dose contained 40 micrograms of HPV-16 L1 virus-like particles and 20 micrograms of HPV-18 L1 virus-like particles adsorbed to aluminum phosphate. The vaccine was administered only in the base study 311-HPV-1004; no study vaccine is administered in 311-HPV-1004-EXTEND.
| Study group | Role | What they receive |
|---|---|---|
| 2-dose adolescent cohort | Participants who were aged 9 to 14 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0 and 6. No vaccine is administered in the extension study. Receives: Biological: Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris) | |
| 3-dose adolescent cohort | Participants who were aged 9 to 14 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0, 2, and 6. No vaccine is administered in the extension study. Receives: Biological: Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris) | |
| 3-dose adult cohort | Participants who were aged 18 to 26 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0, 2, and 6. No vaccine is administered in the extension study. Receives: Biological: Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer of HPV-16 Neutralizing Antibodies
The geometric mean and two-sided 95% confidence interval of HPV-16 neutralizing antibody titers are summarized separately for each prior-vaccination cohort using the high-throughput pseudovirus-based neutralization assay.
Measured: Months 84, 108, and 132 after the first dose in the base study
Geometric Mean Titer of HPV-18 Neutralizing Antibodies
The geometric mean and two-sided 95% confidence interval of HPV-18 neutralizing antibody titers are summarized separately for each prior-vaccination cohort using the high-throughput pseudovirus-based neutralization assay.
Measured: Months 84, 108, and 132 after the first dose in the base study
Seropositivity Rate for HPV-16 Neutralizing Antibodies
The percentage of participants meeting the assay-defined seropositivity threshold for HPV-16 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort.
Measured: Months 84, 108, and 132 after the first dose in the base study
Seropositivity Rate for HPV-18 Neutralizing Antibodies
The percentage of participants meeting the assay-defined seropositivity threshold for HPV-18 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort.
Measured: Months 84, 108, and 132 after the first dose in the base study
Secondary outcomes (4)
Geometric Mean Titer of HPV-16 Neutralizing Antibodies in Stored Serum Samples
The geometric mean and two-sided 95% confidence interval of HPV-16 neutralizing antibody titers measured using the high-throughput pseudovirus-based neutralization assay are summarized separately for each prior-vaccination cohort using available stored serum samples collected in the base study from participants who subsequently enrolled in the long-term extension study.
Measured: Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study
Geometric Mean Titer of HPV-18 Neutralizing Antibodies in Stored Serum Samples
The geometric mean and two-sided 95% confidence interval of HPV-18 neutralizing antibody titers measured using the high-throughput pseudovirus-based neutralization assay are summarized separately for each prior-vaccination cohort using available stored serum samples collected in the base study from participants who subsequently enrolled in the long-term extension study.
Measured: Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study
Seropositivity Rate for HPV-16 Neutralizing Antibodies in Stored Serum Samples
The percentage of participants meeting the assay-defined seropositivity threshold for HPV-16 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort using available stored serum samples collected in the base study from participants who subsequently enrolled in the long-term extension study.
Measured: Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study
Seropositivity Rate for HPV-18 Neutralizing Antibodies in Stored Serum Samples
The percentage of participants meeting the assay-defined seropositivity threshold for HPV-18 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort using available stored serum samples collected in the base study from participants who subsequently enrolled in the long-term extension study.
Measured: Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start25 Mar 2023
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 348 participants (actual)
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
- NCT07820241
- Sponsor's protocol ID
- 311-HPV-1004-EXTEND
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 17 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 to be shared.
Publications
Li J, Shi LW, Li K, Huang LR, Li JB, Dong YL, Li W, Ji M, Yang Q, Zhou LY, Yuan L, Yan XM, Chen JJ, Jiang ZW, Qi YY, Li RC, Li YP, Xia JL, Yu BW, Mo ZJ, Li CG. Comparison of the safety and persistence of immunogenicity of bivalent HPV16/18 vaccine in healthy 9-14-year-old and 18-26-year-old Chinese females: A randomized, double-blind, non-inferiority clinical trial. Vaccine. 2023 Oct 26;41(48):7212-9. doi: 10.1016/j.vaccine.2023.10.041. Online ahead of print.
PubMed 39492306
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Long-term Extension Study to Evaluate the Persistence of Immune Responses to a Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) in Healthy Females Who Were Aged 9 to 26 Years at Enrollment in Study 311-HPV-1004
- ClinicalTrials.gov ID
- NCT07820241
- Acronym / sponsor ID
- 311-HPV-1004-EXTEND
- Conditions
- Human Papillomavirus Infection
- Keywords
- Bivalent HPV vaccine, Immune persistence, Neutralizing antibody, Two-dose vaccination schedule, Long-term follow-up, Pichia pastoris
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Yuxi Zerun Biotechnology Co., Ltd.
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 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 long-term extension study evaluates the persistence of neutralizing antibody responses to a bivalent human papillomavirus vaccine in females who previously participated in study 311-HPV-1004 (NCT02740777). Participants belonged to one of three vaccination cohorts in the base study: adolescents who received two doses at Months 0 and 6, adolescents who received three doses at Months 0, 2, and 6, and adults who received three doses at Months 0, 2, and 6. No vaccine is administered in the extension study. Blood samples are collected at Months 84, 108, and 132 after the first dose in the base study and tested for HPV-16 and HPV-18 neutralizing antibodies using a high-throughput pseudovirus-based neutralization assay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2-dose adolescent cohort | – | Biological: Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)Participants who were aged 9 to 14 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0 and 6. No vaccine is administered in the extension study. |
| 3-dose adolescent cohort | – | Biological: Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)Participants who were aged 9 to 14 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0, 2, and 6. No vaccine is administered in the extension study. |
| 3-dose adult cohort | – | Biological: Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)Participants who were aged 18 to 26 years at enrollment in the base study and received the bivalent HPV vaccine at Months 0, 2, and 6. No vaccine is administered in the extension study. |
Who may qualify
- Ages
- 16 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Females previously enrolled in study 311-HPV-1004 (NCT02740777) at the Hezhou and Zhongshan study sites in Guangxi, China, who completed the required blood-collection visits in the base study and met the eligibility criteria for the extension study.
Key inclusion criteria (3 listed)
- The participant, and the participant's legal guardian when applicable, is able to understand the study information and voluntarily sign the informed consent form for the extension study.
- In the investigator's judgment, the participant is able to comply with protocol requirements, including attending scheduled visits and responding to follow-up telephone contacts.
- The participant was enrolled in study 311-HPV-1004 and completed blood collection at Day 0 and Months 7, 12, 24, and 36.
Key exclusion criteria (4 listed)
- Receipt of any HPV vaccine other than the study vaccine during study 311-HPV-1004 or between completion of that study and enrollment in this extension study.
- Use of an investigational or unregistered product, other than the study vaccine, during study 311-HPV-1004 or between completion of that study and enrollment in this extension study.
- Seropositivity for both HPV-16 and HPV-18 antibodies at baseline in study 311-HPV-1004.
- Long-term use of immunosuppressive agents or
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 |
|---|---|---|
| Bivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)Each 0.5 mL dose contained 40 micrograms of HPV-16 L1 virus-like particles and 20 micrograms of HPV-18 L1 virus-like particles adsorbed to aluminum phosphate. The vaccine was administered only in the base study 311-HPV-1004; no study vaccine is administered in 311-HPV-1004-EXTEND. | Biological | 2-dose adolescent cohort, 3-dose adolescent cohort, 3-dose adult cohort |
Primary outcome
Geometric Mean Titer of HPV-16 Neutralizing Antibodies
Time frame: Months 84, 108, and 132 after the first dose in the base study
The geometric mean and two-sided 95% confidence interval of HPV-16 neutralizing antibody titers are summarized separately for each prior-vaccination cohort using the high-throughput pseudovirus-based neutralization assay.
Geometric Mean Titer of HPV-18 Neutralizing Antibodies
Time frame: Months 84, 108, and 132 after the first dose in the base study
The geometric mean and two-sided 95% confidence interval of HPV-18 neutralizing antibody titers are summarized separately for each prior-vaccination cohort using the high-throughput pseudovirus-based neutralization assay.
Seropositivity Rate for HPV-16 Neutralizing Antibodies
Time frame: Months 84, 108, and 132 after the first dose in the base study
The percentage of participants meeting the assay-defined seropositivity threshold for HPV-16 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort.
Seropositivity Rate for HPV-18 Neutralizing Antibodies
Time frame: Months 84, 108, and 132 after the first dose in the base study
The percentage of participants meeting the assay-defined seropositivity threshold for HPV-18 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort.
4 secondary outcomes
Geometric Mean Titer of HPV-16 Neutralizing Antibodies in Stored Serum Samples
Time frame: Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study
Geometric Mean Titer of HPV-18 Neutralizing Antibodies in Stored Serum Samples
Time frame: Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study
Seropositivity Rate for HPV-16 Neutralizing Antibodies in Stored Serum Samples
Time frame: Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study
Seropositivity Rate for HPV-18 Neutralizing Antibodies in Stored Serum Samples
Time frame: Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study
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 17 Sep 2026.
- Background: PubMed 39492306Li J, Shi LW, Li K, Huang LR, Li JB, Dong YL, Li W, Ji M, Yang Q, Zhou LY, Yuan L, Yan XM, Chen JJ, Jiang ZW, Qi YY, Li RC, Li YP, Xia JL, Yu BW, Mo ZJ, Li CG. Comparison of the safety and persistence of immunogenicity of bivalent HPV16/18 vaccine in healthy 9-14-year-old and 18-26-year-old Chinese females: A randomized, double-blind, non-inferiority clinical trial. Vaccine. 2023 Oct 26;41(48):7212-9. doi: 10.1016/j.vaccine.2023.10.041. Online ahead of print.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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, run by Shanghai Zerun Biotechnology Co.,Ltd at 2 sites 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 4 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 17 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 2 sites 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 HPV-16 Neutralizing Antibodies (time frame: Months 84, 108, and 132 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?
On the ClinicalTrials.gov record for NCT07820241, which also lists 1 linked publication.
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 17 Sep 2026.