Normalizing Antibody Detection in First-void Urine

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age9-70
SponsorUniversiteit Antwerpen

About this trial

The aim of this study is to develop robust analytical protocols for the monitoring of vaccine induced immunity against the Human Papillomavirus (HPV) in first-void urine samples and to examine fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts.

Eligibility criteria

Qualifiers

Vaccinated with either the Cervarix, Gardasil or Gardasil9 HPV-vaccine and able to present vaccination booklet or another official document proving this.

Able to understand the information brochure and what the study is about.

Willing to give informed consent to contact his/her general practitioner and/or gynecologist to access details on their HPV vaccination schedule and, in case a woman within the screening population, cervical cancer screening results (smears, HPV tests, colposcopy, biopsy).

Disqualifiers

Participating in another clinical trial at the same time of participating in this study.

Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the six months prior to study enrolment.

Pregnant women.

Being positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.

Trial design

Treatments tested in this trial

  • Sampling

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Universiteit Antwerpen

Lead sponsor

University Hospital, Antwerp

Collaborator