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Enrolling by invitation

NCT Number: NCT07833852

Long-Term Immune Persistence After Bivalent HPV Vaccination in Females From 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.

Enrolling by invitation

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Shanghai Zerun Biotechnology Co.,Ltd

Industry

Collaborators

  • Yuxi Zerun Biotechnology Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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