Developing a First-void Urine-based Infection Model to Study HPV-specific Antibody-virion Interaction Before and After HPV Vaccination
Recruiting
Phase 2
Interventional Study
Human Papilloma Virus Infection Type 16
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 45
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 50 (estimated)
- Sponsor
- Universiteit Antwerpen · Other
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About This Trial
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…
Trial Locations
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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 t…
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