An observational study in Human Papillomavirus Infection and Cervical Intraepithelial Neoplasia, sponsored by Shanghai Zerun Biotechnology Co.,Ltd. Enrolling by invitation at 1 site in China. Open to female participants aged 12 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Shanghai Zerun Biotechnology Co.,Ltd · Observational
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.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's planned enrollment of 486 is close to the median of 490 across 157 observational studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Shanghai Zerun Biotechnology Co.,Ltd is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Biological: Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris)
Drug page: Human papillomavirus vaccine, L1 type 16, 18
Historical exposure assigned in the base study: three intramuscular 0.5-mL doses at Months 0, 2, and 6.
Drug page: Human papillomavirus vaccine, L1 type 16, 18
Historical exposure assigned in the base study: three intramuscular 0.5-mL doses at Months 0, 2, and 6.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Months 42 and 66 after the first dose in the base study
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.
Time frame: From the first dose in the base study through Month 66 after the first dose
Plan to share: No — Individual participant data are not planned for public sharing.
Started Aug 2024 (actual). Primary completion is estimated for Dec 2026, 28 months after the start.
Of 66 observational studies under Papillomavirus Infections, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 90. This study's planned 28 months is below that.
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Shanghai Zerun Biotechnology Co.,Ltd