This phase IV trial evaluates the long term protection provided by either one or two doses of the 9v human papillomavirus (HPV) vaccine for participants who were part of the ESCUDDO study.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07706673.
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PRIMARY OBJECTIVES:
I. To estimate the Incidence Rate Difference (IRD) and Relative Risk (RR) of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 7 to 10 years following HPV vaccination.
II. To estimate the IRD and RR of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 1 to 10 years following HPV vaccination.
OUTLINE: This is an interventional study. Participants are assigned to 1 of 3 arms.
Arm I (ONE DOSE GARDASIL9): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
Arm II (TWO DOSE GARDASIL9): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
Arm III (UNVACCINATED): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study. These women will be offered HPV vaccination (Gardasil9).
Trial participants with documented persistent type-specific HPV infections will be triaged to colposcopy and may undergo biopsy collection and treatment.
Lead OrganizationNational Cancer Institute
Principal InvestigatorAimee Kreimer
