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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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

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

Other trials in China

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 groups in NCT07820241
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.

25 Mar 2023Dec 2027

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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