HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA, HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA for Human Papillomavirus infection

Inclusion criteria

• {"criterion_text":"- Females between 18 and 45 years old (including both limits) at the time of signing the informed consent form."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- No prior vaccination with a prophylactic HPV vaccine."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Ability to understand the information brochure and what the study is about."}

Exclusion criteria

• {"criterion_text":"- Pregnant at the time of signing informed consent or planning to become pregnant within the full duration of the study."}
• {"criterion_text":"- Concomitantly enrolled in another clinical study of investigational agents."}
• {"criterion_text":"- Acute disease or contraindications for vaccination at the time of enrolment."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Unlikely to adhere to the study procedures, keep appointments, or are planning to relocate from the area prior to completion of the study."}
• {"criterion_text":"- Full hysterectomy."}
• {"criterion_text":"- Anogenital lesion treated in the last twelve months before participating in the study."}
• {"criterion_text":"- Invasive cancer (except basocellular carcinoma) or other immunocompromising conditions as described as high-risk in the latest scientific guidelines from Sciensano."}
• {"criterion_text":"- Use of immunosuppressive therapy for inflammatory bowel disease, rheumatological disorders, neuromyelitis optica, sarcoidosis, adenocarcinoma in situ, or use of local anogenital corticosteroids."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Immunoglobulins or other blood products from day 1 until month 7 of the study."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Known allergy for any component of the Gardasil9TM vaccine."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Detection measured by presence of HPV16 E1^E4 spliced mRNA in HaCaT keratinocytes following infection with virions isolated from participants' first-void urine samples, assessed before and after vaccination with Gardasil-9."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Detection of type-specific HPV antibodies in paired first-void urine and serum samples measured before and after one or two doses of Gardasil-9."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Detection of HPV DNA of listed types in first-void urine samples (molecular DNA detection assays) collected during study follow-up."}

Belgium

Earliest CTIS Part Ii Submission Date

25-07-2025

Latest Decision Or Authorization Date

06-10-2025

Processing Time Days

73

Number Of Sites

3

Number Of Participants

50

Primary sponsor

Full Name

University Of Antwerp

Organisation Type

Educational Institution

Country Of Registered Address

Belgium