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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,372
- 试验地点
- 9
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HPV-2 vaccine group
Participants received the bivalent HPV vaccine (0.5 mL in a 3-dose regimen) in the base study (NCT02733068). No study vaccination will be administered in long-term follow-up study .
干预措施: HPV-16/18 vaccine (Biological)
Placebo group
Participants received the placebo (0.5 mL in a 3-dose regimen) in the base study (NCT02733068). No study vaccination will be administered in long-term follow-up study .
干预措施: Placebo (Biological)
结局指标
主要结局
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
时间窗: Up to 96 months and 120 months after initial vaccination in base study.
次要结局
- Cumulative protective efficacy against cytological HPV-16 and/or HPV-18 infection(Up to 96 months and 120 months after initial vaccination in base study.)
- Cumulative protective efficacy against HPV-16 and/or HPV-18-related CIN1+(Up to 96 months and 120 months after initial vaccination in base study.)
- HPV 16/18 neutralizing antibody GMT and seropositivity rates(At 96 months and 120 months after initial vaccination in base study.)