Collection of First-void Urine Samples for the Development of Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine: the AB-SOP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Concentration HPV specific IgG (Immunoglobulin G) in paired first-void urine and serum samples
研究概览
简要总结
The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and antibody assays to monitor natural and/or vaccine induced immunity against HPV (Human Papillomavirus).
详细描述
In total 57 women will be included in this trial: 38 vaccinated with an prophylactic HPV vaccine and 19 not vaccinated with a prophylactic HPV vaccine. These women are asked to collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood sample of 5-10 cc is collected. The collected urine and blood samples will be used for the development and optimisation of robust analytical protocols for sample preparation and antibody assays.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-26 year
- •Cases (n=38): healthy women, fully vaccinated, i.e. receiving all three doses of the bivalent (Cervarix®) or quadrivalent (Gardasil®) HPV vaccine (according to the KCE (Belgian Knowledge Centre for Health) recommendations: age at first vaccination between 10-25 years for the bivalent and 9-26 years for the quadrivalent vaccine).
- •Cases should be able to prove their vaccination (brand and schedule) with an official document.
- •Control group (n=19): healthy women, self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available (Gardasil®, Cervarix®, Gardasil-9®)
- •Signing informed consent form (ICF).
- •Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF).
排除标准
- •Participating in another clinical study at the same time of participating in this study.
- •Not able to understand the information brochure/what the study is about
- •Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
结局指标
主要结局
Concentration HPV specific IgG (Immunoglobulin G) in paired first-void urine and serum samples
时间窗: Within 6 months after study completion
To detect HPV specific IgG concentrations (ratio HPV specific IgG/total human IgG), in paired first-void urine and serum samples from 57 women to monitor the immune response after vaccination with a prophylactic HPV vaccine (Gardasil or Cervarix).
次要结局
- Concentration HPV specific IgA (Immunoglobulin A) in paired first-void urine and serum samples(Within 6 months after study completion)
研究者
Pierre Van Damme
Professor Pierre Van Damme, MD, PhD
Universiteit Antwerpen