Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (ABSOP-FollowUp)

Universiteit Antwerpen

Status: Completed

Conditions: Human Papilloma Virus Infection

Treatments: Other: Blood draw; Other: First-void urine collection

Study type: Observational

Funder types: Other

Identifiers

NCT03542227

B300201734258

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 63 patients

Sex: Female

Ages: 16 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Participant of the HPV V503-004 study at UA/UZA
• Willing to give informed consent (ICF) to the CEV research team