Clinical trial · Observational
Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples
Developing Methods to Investigate Additional Opportunities of HPV Vaccination, Including Control of Infection and Transmission, by Using a Cervicovaginal Human Sample, Collected by Urination (HPV-VACPLUS)
NCT04391647CI-TRIAL-00054171HPV-VACPLUScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this study is to develop protocols using FV urine that investigate in vitro whether infectious virions can be neutralized by HPV vaccination.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papilloma Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Other | — | UNRESOLVED |
| First-void urine collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- HPV vaccinated group
- description
- Women (18-25 years old) whom are previously fully vaccinated with the bivalent (Cervarix), quadrivalent (Gardasil) or nonavalent (Gardasil) prophylactic HPV vaccine. No intervention/drug to be administered.
- interventionNames
- Other: First-void urine collection
- Other: Blood draw
- label
- HPV unvaccinated group
- description
- Women (18-25 years old) whom are not previously vaccinated with the bivalent (Cervarix), quadrivalent (Gardasil) or nonavalent (Gardasil) prophylactic HPV vaccine. No intervention/drug to be administered.
- interventionNames
- Other: First-void urine collection
- Other: Blood draw
Primary outcomes (1)
- measure
- Protocols to investigate the neutralizing ability of HPV vaccine-induced antibodies
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Female * 18-25 years of age * Sexually active or has been sexually active in the past * Cases (n=25): fully vaccinated women, i.e. receiving all necessary doses of the HPV vaccine (according to the KCE recommendations) able to prove their vaccination (brand and schedule) with an official document. * Control group (n=25): women self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available. * Willing to give informed consent to the CEV research team. * 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) Exclusion Criteria: * Women participating in another clinical study at the same time of this study. * Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.
References
Publications (0)
Data not yet available
No reference posted for this study.