An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination Regimen Over 6 Months Among Women Aged 16 to 45 Years Old, An Exploratory Immunogenicity Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Change in geometric mean titers ratios
研究概览
简要总结
The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9 among women aged 16-26 years old. The investigators thought that having a 2-dose vaccination regimen for individuals 16 to 45 would provide a more robust dataset than those of 27 to 45 years old.
详细描述
The investigators will identify potential eligible subjects from the Boston Medical Center (BMC) Clinical Data Warehouse from the following BMC clinics: Pediatrics, Adolescent Medicine, Family Medicine, Obstetric/ Gynecology (OB/GYN), and Women's Health/Adult Primary Care. The research team will mail a recruitment opt-out letter signed by the principal investigator to the participant along with a study flyer. The recruitment letter will inform the participant that a research member may contact them via phone within two week to provide more information regarding the study.
Participants opting-in will be called and interviewed with the study recruitment script and eligibility will be determined. Eligible participants who agree to participate (in-person or over the phone), will be scheduled to come to the Boston University (BU) General Clinical Research Unit (GCRU) to complete the consent process. At the baseline visit participants will be assigned into the appropriate group (control vs. intervention) based on their age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women receiving care at Boston Medical Center
排除标准
- •Currently pregnant
- •Prior HPV vaccination
- •A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic to yeast
- •Immunocompromised/previous immunosuppressive therapy
- •Thrombocytopenia or other coagulation disorder
- •Currently breastfeeding
研究组 & 干预措施
Intervention group
240 eligible women will receive a 2-dose regimen of Gardasil 9 at (0 and 6 months, followed by a rescue 3rd dose at month 12)
干预措施: Gardasil 9 2 dose regimen (Drug)
Intervention group
240 eligible women will receive a 2-dose regimen of Gardasil 9 at (0 and 6 months, followed by a rescue 3rd dose at month 12)
干预措施: Gardasil 9 rescue dose (Drug)
Control group
120 eligible women will receive the standard 3-dose regimen of Gardasil 9 at (0, 2, 6 months)
干预措施: Gardasil 9 3 dose regimen (Drug)
结局指标
主要结局
Change in geometric mean titers ratios
时间窗: baseline and 7 months
The geometric mean titers (GMT) ratios will be determined by a post-vaccination geometric mean titer (GMT) ratio with a pre-stated analysis of variance model (95% Confidence Interval lower bound \>0.5).
Change in immunogenicity of Gardasil 9
时间窗: baseline and 7 months
Immunogenicity will be measured by serum antibodies assessed by ELISA to the nine HPV types (anti-HPV 6/11/16/18/31/33/45/ 52/58 where positive anti-HPV serum levels are defined as \>30, \>16, \>20, \>24, \>10, \>8, \>8, \>8, or \>8 milli Merck units (mMU)/mL respectively).
次要结局
- Number of participants with HPV seropositivity at day 1(day 1)
- Number of participants with HPV seropositivity at month 7(month 7)