Developing a first-void urine-based infection model to assess HPV virion infectivity after vaccination.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Antwerp

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Virus Diseases [C02], Phenomena and Processes [G] - Immune System Phenomena [G13]

Trial duration

25 Mar 2026 → ongoing

Decision date (initial)

2025-08-08

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others

To examine the interaction between vaccine-induced HPV type-specific antibodies and HPV virions in an in vitro infection model using first-void urine samples.

Secondary objectives 2

1. To follow-up HPV type-specific antibody responses in first-void urine after natural infection and vaccination with the Gardasil-9TM vaccine and to compare these with the responses in serum.
2. To follow-up HPV infections over time using first-void urine.

Conditions and MedDRA coding

Human Papillomavirus infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Females between 18 and 45 years old (including both limits) at the time of signing the informed consent form.
2. Tested positive for HPV16 (singular or co-infection) but no presence of apparent anogenital lesions and are thus not referred for treatment or intervention at the time of inclusion or within the last twelve months before inclusion.
3. No prior vaccination with a prophylactic HPV vaccine.
4. Willing to give informed consent to the study team to access medical records, including details on their HPV vaccination schedule and cervical cancer screening results (smears, HPV tests, colposcopy, biopsy).
5. Ability to understand the information brochure and what the study is about.

Exclusion criteria 13

1. Pregnant at the time of signing informed consent or planning to become pregnant within the full duration of the study.
2. Full hysterectomy.
3. Anogenital lesion treated in the last twelve months before participating in the study.
4. Invasive cancer (except basocellular carcinoma) or other immunocompromising conditions as described as high-risk in the latest scientific guidelines from Sciensano.
5. Use of immunosuppressive therapy for inflammatory bowel disease, rheumatological disorders, neuromyelitis optica, sarcoidosis, adenocarcinoma in situ, or use of local anogenital corticosteroids.
6. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planning to use during the study period.
7. Immunoglobulins or other blood products from day 1 until month 7 of the study.
8. Any vaccine not foreseen in the study protocol administered in the period beginning 30 days preceding each dose of the study vaccine and ending one month (minimum 30 days) after each dose of the study vaccine.
9. Known allergy for any component of the Gardasil9TM vaccine.
10. Concurrently enrolled in another clinical study of investigational agents.
11. Acute disease or contraindications for vaccination at the time of enrolment.
12. History or current evidence of any condition or abnormality that might confound the results of the study or is not in the best interest of the individual to participate, in the opinion of the investigator.
13. Unlikely to adhere to the study procedures, keep appointments, or are planning to relocate from the area prior to completion of the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 2

1. 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.
2. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Antwerp

Sponsor organisation

University Of Antwerp

Address

Drie Eikenstraat 663

City

Edegem

Postcode

2650

Country

Belgium

Scientific contact point

Organisation

University Of Antwerp

Contact name

Alex Vorsters

Public contact point

Organisation

University Of Antwerp

Contact name

Margo Bell

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 33 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications