Immunogenicity of Fractional Dose of the Bivalent and Nonavalent Intradermal HPV Vaccines.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- HPV antibody detection after fractional HPV vaccination
研究概览
简要总结
This randomized phase IV trial compares fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, 12 months, and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 27 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 27-45 years at enrollment
- •Not intending to receive the HPV vaccine series for the duration of the study participation
- •Willing and able to provide written informed consent, undergo clinical evaluation, and adhere to follow-up schedule
排除标准
- •Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
- •Currently pregnant or breastfeeding
- •Immune deficiency or other immune disorder
- •HIV infection or continued high risk for HIV; patients at risk for HIV who do not have a negative HIV test in the last 6 months will be excluded
- •Cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer)
- •Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes,
- •Known allergy to vaccine components
- •Prior history of HPV-associated cancer
研究组 & 干预措施
Bivalent HPV vaccine
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously
干预措施: HPV vaccine (Biological)
Nonavalent HPV vaccine
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously
干预措施: HPV vaccine (Biological)
结局指标
主要结局
HPV antibody detection after fractional HPV vaccination
时间窗: 12 months
HPV antibody response after delivery of a single, intradermal, fractional dose of the HPV-2 or HPV-9 vaccines
次要结局
未报告次要终点
研究者
Anna Wald
Professor: School of Medicine
University of Washington