Study for the Development of Standard Operating Procedures for Anti-HPV Antibody Detection in First-void Urine: the AB-SOP Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Concentration of HPV specific IgG (Immunoglobulin G) in FV urine.
研究概览
简要总结
The aim of the study is to develop and implement robust analytical protocols for first-void urine sample preparation and antibody assays to monitor vaccine induced immunity against HPV (Human Papillomavirus).
详细描述
Participants of the HPV V503-004 study (Phase III Clinical trial vaccinating (young) adult women in Antwerp, EudraCT NUMBER: 2015-005093-38) will be asked if they are willing to provide two additional urine samples at day 1 and month 7 for biomedical research. Furthermore, they will be contacted again at approximately 3.5 years and asked if they are willing to provide an additional urine sample and a serum sample. At 3.5 years, they will also be asked to fill in a brief questionnaire. The collected urine will be used for the development and optimization of robust analytical protocols for sample preparation and antibody assays.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant of the HPV V503-004 study at UA/UZA
- •Willing to give informed consent (ICF) to the CEV research team
排除标准
- 未提供
结局指标
主要结局
Concentration of HPV specific IgG (Immunoglobulin G) in FV urine.
时间窗: Within 6 months after study completion
To detect HPV specific IgG concentrations (ratio HPV specific IgG/total human IgG), in first-void urine from 63 women to monitor the immune response before and after vaccination with a prophylactic HPV vaccine (Gardasil9).
次要结局
未报告次要终点
研究者
Pierre Van Damme
Principal investigator
Universiteit Antwerpen