Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Determine the HPV vaccine immunogenicity in females 12-26 years with six special risk groups at one month post the third and final HPV vaccination. Blood analysis taken at one month post third and final HPV vaccine to assess immunogenicity.
研究概览
简要总结
A research project is currently being undertaken looking at Human Papilloma Virus (HPV) vaccination in special risk groups. It aims to see if young women with a chronic illness respond well to the HPV vaccine or whether they may require additional doses to ensure protective immunity. The four valent HPV vaccine protects against HPV types 16 & 18, cervical cancer and HPV types 6 & 11, anogenital warts.
The six special risk groups include:
Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow Transplants This immunity is measured by antibody levels of the HPV types, which requires a single blood test one month after the final dose of HPV vaccine.
This is compared to healthy controls using antibody response to HPV vaccine. This will assess directly whether these special risk groups respond as well to the HPV vaccine.
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
- 12 Years 至 26 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 12-26 years
- •Have been diagnosed by a specialist with one of the six chronic medical conditions described:
- •Paediatric Rheumatological Disease
- •Inflammatory Bowel Disease
- •Acute Lymphoblastic Leukaemia
- •Solid Organ Transplant Recipients (kidney and liver)
- •Chronic Renal Disease
- •Bone Marrow Transplant
排除标准
- •Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis
结局指标
主要结局
Determine the HPV vaccine immunogenicity in females 12-26 years with six special risk groups at one month post the third and final HPV vaccination. Blood analysis taken at one month post third and final HPV vaccine to assess immunogenicity.
时间窗: One Month post HPV vaccination
次要结局
- Describe the safety of the HPV vaccine in the six study groups using self reports and liaison with treating sub specialist team.(One month post third HPV vaccination)