Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Immunogenicity After Dose 3
研究概览
简要总结
The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months.
Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C):
H0: δ ≤ -δ0 versus H1: δ > -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin
详细描述
- Specific Aims and Overview: The investigators propose a randomized, open label trial of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months.
Blood would be drawn for titers at twice from all participants: pre-dose 1 and one month post Dose 3.
No cytology studies or DNA studies will be conducted.
1.1 Aims:
- Determine if delay in the third dose is immunologically non-inferior to the standard administration schedule (1 month post-dose 3).
- Determine the side effect profile of a delayed third dose, in comparison to the standard schedule.
- Determine the preference and compliance of the men for the timing of the third dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males age 18-26
排除标准
- •Hospitalization within the past year
- •Previous HPV vaccination
- •>/=5 sexual partners (i.e., insertive intercourse) No other drug studies within 30 days of proposed HPV vaccination
- •History of genital warts
- •Immunosuppression
- •Other vaccines within 8 days of proposed HPV vaccination
- •Hypersensitivity to yeast or HPV vaccine components
- •Known autoimmune disorders
- •Receipt of immunoglobulins or blood product within 90 days of enrollment (may defer until 90 days completed)
- •Serious Adverse Reaction to HPV vaccine
结局指标
主要结局
Immunogenicity After Dose 3
时间窗: 1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)
Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.
次要结局
- Compliance With 3rd Dose(at 3rd dose (i.e., at month 6 or month 12, depending on arm))
- Safety Profile(1 week after vaccination)
研究者
Richard Zimmerman
Professor
University of Pittsburgh