Study of HPV Vaccine Antibody Detection in First-void Urine Samples from Different Age and Gender Groups

What this Trial Is About

Researchers are studying how to improve the monitoring of vaccine-induced immunity against Human Papillomavirus HPV using a non-invasive method. This study focuses on developing reliable ways to detect HPV-specific antibodies in first-void urine samples, which can be self-collected at home. This approach could offer a more acceptable and practical alternative to traditional invasive methods like cervical, blood, or vaginal samples. The study aims to reduce variability in urine samples to make this method suitable for vaccine research. The study includes 150 participants divided into six groups pre-adolescent girls, women using different types of contraceptives or none, post-menopausal women, and men, all vaccinated against HPV. Over 36 days, participants will self-collect between 6 and 21 first-void urine samples using a device called Colli-Pee. They will also visit the study site twice for blood samples on day 1 and day 36. The samples will be analyzed to study antibody levels, menstrual cycle effects, and HPV DNA presence. Participants will be monitored through their self-collected urine samples and blood tests. The research team will examine fluctuations in HPV-specific antibodies and test for other biomarkers to better understand variability. The main outcome measured is the concentration of total and HPV-specific IgG antibodies in the urine within six months after study completion. Secondary outcomes include antibody levels in blood and HPV DNA status. The study supports long-term monitoring of immune responses with non-invasive sampling methods.

Normalizing Antibody Detection in First-void Urine