Immunogenicity of Fractional Dose of the HPV Vaccines
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- HPV antibody detection after intradermal or intramuscular, fractional one-fifth dose HPV-2 or HPV-9 vaccine immunization
研究概览
简要总结
This randomized phase IV trial compares intramuscular and intradermal 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, and 12 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, adhere to follow-up schedule
排除标准
- •Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
- •Currently pregnant or breastfeeding
- •Immunedeficiency disease/condition or cancer that causes clinically significant immunosuppression
- •Known HIV infection
- •Chemotherapy (current or within 12 months) or currently taking a medication that causes clinically significant immunosuppression.
- •Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes)
- •Known allergy to vaccine components
- •Prior history of HPV-associated cancer
- •Any medical condition which, in the opinion of the investigator, may compromise the subject's ability to safely complete the study.
研究组 & 干预措施
IM Bivalent HPV vaccine
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered intramuscularly
干预措施: HPV vaccine (Biological)
ID Bivalent HPV vaccine
One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously
干预措施: HPV vaccine (Biological)
IM Nonavalent HPV vaccine
One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered intramuscularly
干预措施: HPV vaccine (Biological)
ID 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 intradermal or intramuscular, fractional one-fifth dose HPV-2 or HPV-9 vaccine immunization
时间窗: 12 months
To describe the changes in vaccine-type HPV antibody detection measured by Luminex assay between baseline and 12 months after vaccination.
次要结局
未报告次要终点
研究者
Anna Wald
Professor: School of Medicine
University of Washington