BridgeMD
New treatment option for Human Papilloma Virus Infection Type 16
Official title Developing a First-void Urine-based Infection Model to Study HPV-specific Antibody-virion Interaction Before and After HPV Vaccination
ClinicalTrials.gov ID: NCT07407569
What this study is testing
What is Gardasil 9 (2 dose regimen)?
Gardasil 9 (2 dose regimen) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for human papilloma virus infection type 16.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The current study is an open-label, non-randomized, longitudinal exploratory trial using the licensed Gardasil 9 (9vHPV) vaccine in an off-label context to investigate biological and immunological outcomes in human papillomavirus type 16 (HPV16) positive women. Two doses of the licensed Gardasil 9 vaccine will be administered to approximately 50 women between 18 and 45 years old, who test positive for HPV16 DNA at baseline using a type-specific quantitative PCR assay, but have no presence of apparent anogenital lesions and are thus not referred for treatment or intervention at the time of inclusion.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Candidates are eligible for inclusion in the study if they:
- Are females between 18 and 45 years old (including both limits) at the time of signing the informed consent form.
- Have tested positive for HPV16 DNA (single or co-infection) but have no presence of apparent anogenital lesions and are thus not referred for...
- Did not receive prior vaccination with a prophylactic HPV vaccine.
- Are able to understand the information brochure and what the study is about.
See the full eligibility criteria
- Candidates are eligible for inclusion in the study if they:
- Are females between 18 and 45 years old (including both limits) at the time of signing the informed consent form.
- Have tested positive for HPV16 DNA (single or co-infection) but have 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...
- Did not receive prior vaccination with a prophylactic HPV vaccine.
- Are able to understand the information brochure and what the study is about.
- Are willing to give informed consent to the study team to access their medical records, including details on their HPV vaccination schedule and cervical cancer screening results (smears, HPV tests, colposcopy, biopsy)...
- Are previously (completely or partially) vaccinated against HPV or have planned administration of another HPV vaccine during the study.
- Are pregnant at the time of signing informed consent or are planning to become pregnant within the full duration of the study. Participants must use an effective method of contraception throughout the entire study...
- Have had full hysterectomy.
- Have had any anogenital lesion treated in the last twelve months before participating in the study.
- Have invasive cancer (except basocellular carcinoma) or other immunocompromising conditions as described as high-risk in the latest scientific guidelines from Sciensano.
- Use immunosuppressive therapy for inflammatory bowel disease, rheumatological disorders, neuromyelitis optica, sarcoidosis, adenocarcinoma in situ, or use of local anogenital corticosteroids.
- Have used 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.
- Have received immunoglobulin or blood-derived products in the three months prior to the first study vaccination (Month 0), or are expected to require immunoglobulin or blood-derived products from Month 1 until Month 7...
- Receive 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.
- Have known allergy or history of any reaction or hypersensitivity likely to be exacerbated by any component of the Gardasil 9 vaccine or known history of severe allergic reaction to other vaccines (e.g. anaphylaxis).
- Are concurrently enrolled in another clinical study of investigational agents.
- Have acute disease or contraindications for vaccination at the time of enrolment. Acute disease is defined as the presence of moderate or severe illness with or without fever. Enrolment will be deferred until the...
- Have a 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.
- Are, as determined by the investigator, unlikely to adhere to the study procedures, keep appointments, or are planning to relocate from the area prior to completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Wilrijk, Belgium
- Ghent, Belgium
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Wilrijk, Belgium; Ghent, Belgium; Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.