Phase III, Single-center Clinical Trial to Evaluate the 4-valent HPV Vaccine for the Treatment and Prevention of Recurrent Respiratory Papillomatosis in Children
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Papilloma relapses
研究概览
简要总结
Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process.
After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.
详细描述
- Enrollment
-
ear-nose-throat (ENT) examination + oesophagoscopy
-
immunological assessment
-
assessment of selected humoral (antibodies) and
-
cellular immune response parameters(INF gamma and granzyme B testing)
-
in vitro and in vivo stimulation of PMBCs with the HPV-4 vaccine
- Immunization with 4-valent HPV vaccine at 0,2,6 months
- Follow up
- 1 month after 3rd vaccine dose - immunological assessment (same tests as in the enrollment phase)
- 6, 12 and 18 months after the 3rd vaccine dose - ENT + oesophagoscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •respiratory papillomatosis
- •at least 3 relapses in patient history
- •HPV 6 and/or 11 positive papillomas
- •able to mount neutralizing antibodies
排除标准
- •other chronic underlying condition
- •other HPV type
- •no antibody response
结局指标
主要结局
Papilloma relapses
时间窗: 18 months after the 3rd vaccine
Number of relapses and surgical treatment needed after the 3rd vaccine dose during the 18--months follow-up period
次要结局
未报告次要终点
研究者
dr. med habil Zsófia Meszner PhD
Professor
National Institute of Child Health, Hungary