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.
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 months before inclusion.
Did not receive prior vaccination with a prophylactic HPV vaccine.
Are able to understand the information brochure and what the study is about.
None
Single group
Gardasil 9 (2 dose regimen)
Biological/VaccineAll subjects will be administered a 0.5 mL dose of the vaccine as an intramuscular injection in the deltoid following a two-dose schedule (0 months and 6 months). The Gardasil 9 vaccine is authorized and indicated for active immunization in individuals from the age of 9 years for the prevention of premalignant lesions and cancers aeecting the cervix, vulva, vagina and anus and genital warts caused by HPV types.
Detection of HPV16 E1^E4 spliced mRNA in an in vitro infection model using first-void urine samples
Presence and relative expression level of HPV16 E1\^E4 spliced mRNA in HaCaT keratinocytes following in vitro infection with HPV virions isolated from first-void urine samples collected before and after administration of two doses of the Gardasil 9 vaccine.
Detection of HPV type-specific antibodies in first-void urine and serum samples
Presence and level of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type-specific antibodies in paired first-void urine and serum samples collected before and after administration of one or two doses of the Gardasil 9 vaccine.
Detection of HPV DNA in first-void urine samples
Presence of HPV DNA for genotypes 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 66, 68, 69, 70, 73, and 82 in first-void urine samples collected during follow-up.
Click on the lead sponsor to view all of their trials.
Universiteit Antwerpen
Lead sponsor
University Hospital, Antwerp
Collaborator
University Hospital, Ghent
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
