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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 486
- 试验地点
- 1
- 主要终点
- Geometric Mean Titer of Neutralizing Antibodies Against HPV-16
研究概览
简要总结
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.
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
- 12 Years 至 34 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •Participants in the breakthrough-case cohort agreed to scheduled remote or site follow-up and to provide relevant HPV- and cervical-disease information.
排除标准
- •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.
研究组 & 干预措施
Clinical-Scale Vaccine Cohort
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.
干预措施: Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris) (Biological)
Commercial-Scale Vaccine Cohort
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.
干预措施: Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Pichia pastoris) (Biological)
结局指标
主要结局
Geometric Mean Titer of Neutralizing Antibodies Against HPV-16
时间窗: 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.
Geometric Mean Titer of Neutralizing Antibodies Against HPV-18
时间窗: 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.
Percentage of Participants Seropositive for Neutralizing Antibodies Against HPV-16
时间窗: 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.
Percentage of Participants Seropositive for Neutralizing Antibodies Against HPV-18
时间窗: 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.
次要结局
- Number and Percentage of Participants With HPV-16- and/or HPV-18-Related CIN2+ Breakthrough Cases(From the first dose in the base study through Month 66 after the first dose)