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NCT07407569
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. The primary objective of this study is to demonstrate that vaccination with a two-dose regimen of the 9vHPV vaccine reduces the viral infectivity of particles in the female genital tract of HPV16-positive women, by using first-void urine samples. The secondary objectives are to follow up HPV type-specific antibody responses in these first-void urine samples after natural infection and vaccination after one or two doses of the 9vHPV vaccine and to compare these with the responses in serum, and to monitor HPV infections in first-void urine over time. Candidates will be selected for participation based on the result of their HPV DNA test performed on a sample collected during routine screening or symptomatic (opportunistic) testing in one of the following centers: * The University Hospital of Antwerp (UZA). * The University Hospital of Leuven (UZ Leuven). * Ghent University Hospital (UZ Gent). Women are followed for up to 24 months, in which first-void urine and serum samples will be collected at different timepoints. The following laboratory procedures will be applied to reach study objectives * Assessment of HPV DNA positivity: HPV genotyping in first-void urine samples. * Assessment of HPV infectivity: Detection of HPV16 E1\^E4 spliced mRNA in HaCaT keratinocytes after infection with virions from first-void urine samples. * Assessment of HPV immunogenicity: Detection of HPV-specific antibodies in first-void urine and serum samples.
NCT02733068
A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy Females Aged 18-30 Years.
NCT02546752
This primary goal of this study is to assess whether patient whose parents watch a standardized digital video using the integrated digital approach during a routine office visit are more likely to accept a dose of HPV vaccine (1st, 2nd, or 3rd dose) compared to those not completing the program. The study team anticipates eligible patients in the intervention clinics to have higher rates of HPV vaccine acceptance (1st, 2nd, or 3rd doses) than patients in the usual care comparison clinics. Additionally, the study team is interested in determining the impact of the integrated system on clinical workflow by measuring the number of minutes of each patient office visit when using the system compared to the number of minutes of each visit in offices where the system is not used. Although this is a descriptive/exploratory aim, our expectation is that the THEO system will have minimal impact on patient flow.