A Pilot Study of the Immunogenicity of a Two-dose Protocol for 9-valent Human Papilloma Virus Vaccination in Postpartum Girls and Women (15-45 Years Old) Previously Unvaccinated Against HPV
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 4
- 主要终点
- Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer
研究概览
简要总结
The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum care at Johns Hopkins University. The investigators will measure the immunogenicity and acceptability of the vaccine in the postpartum setting.
详细描述
This is a pilot, non-inferiority clinical trial using historical controls. Participants will have whole blood drawn at 0 months, 6 months, and 7 months and receive the HPV vaccine at 0 months, 6 months, and 12 months. Each blood draw will consist of one 15mL red top tube to measure HPV serologies and hormone levels. All blood samples collected will be analyzed at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants biologically born as females between the ages of 15 through 45 who have delivered a live born baby within the past 72 hours.
排除标准
- •Pregnancy
- •Severe allergic reaction to vaccine components
- •Prior receipt of an HPV vaccine dose
- •Fetal demise or stillbirth
- •Allergy to latex or yeast
- •Moderate or severe acute illness (deemed by the investigator to exclude)
- •Immunosuppression (e.g., HIV, solid organ transplant).
结局指标
主要结局
Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer
时间窗: Up to 23 months
Measure the immunogenicity of a two-dose 9-valent HPV vaccination regimen in postpartum women previously unvaccinated against the HPV 16 virus. Immunogenicity will be assessed by the antibody responses. The Geometric mean titers will be measured using milli Merck units (mMU)/mL.
次要结局
- Antibody Response to the Other 8 HPV Types(Up to 23 months)
- Seropositivity for HPV 16 After 1-dose(After the first dose, up to 7 months)
- Percentage of Participants Who Complete 2-dose Vaccination(At the end of the study, up to 2 years)
- Seropositivity for HPV 16 After 2-doses(After the second dose, up to 2 months)
- Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16(Baseline)