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NCT Number: NCT06776055

Long-term Follow-up of Bivalent Human Papillomavirus (HPV) Vaccine Study in Women

This extension study aims to evaluate the long-term protection and immune response of the bivalent HPV vaccine in women aged 18-30 who participated in a previous efficacy study (311-HPV-1003). Participants will be monitored over two years, with two visits at 96 and 120 months after their initial vaccination. No additional vaccine doses will be given. Cervical samples will be obtained for ThinPrep Cytologic Testing (TCT) and HPV DNA typing. If applicable, participants meeting referral criteria for colposcopy will undergo the procedure during these visits, and tissue samples will be collected from those requiring a biopsy. Blood samples will be drawn from an immunology subset for antibody testing.The study includes data collection from multiple sites across China to assess the vaccine's long-term efficacy in preventing HPV-related cervical diseases and its durability over time.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cervical Cancer CIN - Cervical Intraepithelial Neoplasia Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus Infection Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Virus Diseases Vulvar Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year–30 year

Sex eligibility

Female

Study type

Observational

Primary location

Lingchuan Center for Disease Control and Prevention, Lingchuan, Guangxi, China

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Have the ability to understand and provide informed consent by signing the informed consent form (non-illiterate).
  • Have the ability to comply with protocol requirements, such as attending scheduled visits and responding to follow-up phone calls.
  • Prior enrollment in the 311-HPV-1003 study, with at least one dose of the study vaccine administered.
  • At least one documented gynecological visit between 6 and 48 months during the previous 311-HPV-1003 study.
  • Refrain from vaginal intercourse for 48 hours and avoid behaviors such as vaginal douching or using vaginal medications that could interfere with gynecological examinations or sample collection for 72 hours prior to each gynecological visit.

Exclusion criteria

  • Participants who received another HPV vaccine during the prior 311-HPV-1003 study or between the end of that study and enrollment in this extension study.
  • Participants diagnosed with HPV 16- or 18-related CIN2+ by an independent pathology expert panel during the prior 311-HPV-1003 study, or who were definitively diagnosed with HPV 16- or 18-related CIN2+ through external testing after the prior study ended.
  • Participants who, at baseline in the 311-HPV-1003 study, tested positive for both HPV 16 and 18 antibodies, or were positive for both HPV 16 and 18 (by Cobas 4800), or whose cytology was not normal or of low-grade changes.
  • Participants who are pregnant at the time of gynecological visits or within three months prior to the visit.
  • Participants with any other factors deemed unsuitable for participation in the clinical trial, as determined by the investigator.

Treatment and study plan

HPV-16/18 vaccine

Biological

Recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast)

Placebo

Biological

Placebo containing the same formulation as the active vaccine (Type 16 and 18 L1 proteins, Yeast) but without the active substance.

Primary outcomes

  1. Cumulative Protective Efficacy Against HPV-16 and/or HPV-18-Related Cervical Intraepithelial Neoplasia (CIN) Grade 2 or Higher (CIN2+), Adenocarcinoma In Situ (AIS), and Cervical Cancer

    Time frame: Up to 96 months and 120 months after initial vaccination in base study.

Secondary outcomes

  1. Cumulative protective efficacy against cytological HPV-16 and/or HPV-18 infection

    Time frame: Up to 96 months and 120 months after initial vaccination in base study.

  2. Cumulative protective efficacy against HPV-16 and/or HPV-18-related CIN1+

    Time frame: Up to 96 months and 120 months after initial vaccination in base study.

  3. HPV 16/18 neutralizing antibody GMT and seropositivity rates

    Time frame: At 96 months and 120 months after initial vaccination in base study.

Sponsors and collaborators

Lead sponsor

Shanghai Zerun Biotechnology Co.,Ltd

Industry

Collaborators

  • Yuxi Zerun Biotechnology Co., Ltd.

Registry information

Official study title

A Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Protective Efficacy and Immunogenic Persistence of the Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) Administered to Healthy Females Aged 18-30 During the 311-HPV-1003 Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

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

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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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