Developing a first-void urine-based infection model to study HPV-specific antibody-virion interaction before and after vaccination with the Gardasil-9 HPV vaccine – a non-randomized open-label study.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522053-18-00

Acronym

URVIVE

Enrollment

Registered

2025-08-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus infection

Brief summary

Detection of HPV16 E1^E4 spliced mRNA in HaCaT keratinocytes after infection with virions isolated from first-void urine samples before and after Gardasil-9TM vaccination.

Detailed description

Detection of HPV 6/11/16/18/31/33/45/52/58 specific antibodies in first-void urine and serum samples before and after one or two doses of the Gardasil-9TM vaccine., Detection of HPV 6/11/16/18/26/31/33/35/39/40/42/43/44/45/51/52/54/56/58/59/61/66/68/59/61/66/68/69/70/73/82 DNA in first-void urine samples.

Interventions

DRUGGardasil 9 suspension for injection in a pre-filled syringe. Human Papillomavirus 9-valent Vaccine (Recombinant

DRUGadsorbed)

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Detection of HPV16 E1^E4 spliced mRNA in HaCaT keratinocytes after infection with virions isolated from first-void urine samples before and after Gardasil-9TM vaccination.	—

Secondary

Measure	Time frame
Detection of HPV 6/11/16/18/31/33/45/52/58 specific antibodies in first-void urine and serum samples before and after one or two doses of the Gardasil-9TM vaccine., Detection of HPV 6/11/16/18/26/31/33/35/39/40/42/43/44/45/51/52/54/56/58/59/61/66/68/59/61/66/68/69/70/73/82 DNA in first-void urine samples.	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026