Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination (Version IV Dated 24Oct2017)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- # of participants with elevated HPV antibody titers from baseline to 7 months
研究概览
简要总结
Currently there are no standards for healthcare worker vaccination with the HPV, Gardasil-9 vaccine. For health care workers, the CDC only recommends for vaccination against hepatitis B, influenza virus, Measles, Mumps and Rubella (MMR), Chickenpox (Varicella), Tetanus, Diptheria, and Pertussis (Tdap), and meninogococcal infections6
详细描述
Initial antibody titers will be measured immediately prior to initial vaccination (month 0). This will entail a blood-draw sample (less than 1 teaspoon) that will be sent to FOCUS labs for evaluation. This will be paid for by funding received from Merck.
The three-dose vaccination schedule will be followed with injections at month 0, 2, and 6. Gardasil 9 dosing will be per the recommended and approved labeled guidelines. Post-vaccination titers would be measured at month 7, which is in alignment with the methods of previous studies. This will entail a blood-draw sample (less than 1 teaspoon) that will be sent to FOCUS labs for evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 27 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Actively practicing attending surgeon in the field of Otolaryngology, General Surgery, Urology, or Obstetrics-Gynecology employed by EVMS or credentialed by CHKD and/or SNGH.
- •Current residents of EVMS Otolaryngology, General Surgery, Urology, or Obstetrics-Gynecology programs
排除标准
- •• Age 26 or younger
- •Age over 69
- •Hypersensitivity to vaccine component
- •History of severe allergic or hypersensitivity reactions to yeast
- •History of previous HPV vaccination with 9 valent vaccine
- •Moderate or severe acute illness
结局指标
主要结局
# of participants with elevated HPV antibody titers from baseline to 7 months
时间窗: baseline and 7 months
baseline change at 7 months post vaccine series. The antibody titer laboratory test will be used to record the levels
次要结局
未报告次要终点
研究者
Craig Derkay M.D.
Professor
Eastern Virginia Medical School