A Non-Randomized, Open-Label Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV16/18-Positive Women After Vaccination With 9vHPV, a Multivalent L1 Virus-like Particle Vaccine, Evaluated in Cervical, Anal and Oral Samples Obtained After One, Two, and Three Vaccine Doses (RIFT-HPV1/RIFT-HPV2)

What this Trial Is About

Researchers are evaluating the effect of the 9-valent HPV vaccine (9vHPV/Gardasil-9™) on reducing the infectivity and transmission of Human Papillomavirus (HPV) types 16 and/or 18 in women who test positive for these types in cervical, oral, and anal samples. This non-randomized, open-label Phase 4 study aims to show that a 3-dose vaccination regimen can lower the ability of HPV to infect cells and be passed to sexual partners, based on the production of specific antibodies triggered by the vaccine. Secondary goals include measuring antibody levels for all nine HPV types covered by the vaccine and assessing infectivity reduction after one or two doses as well. Participants receive the 9vHPV vaccine in a three-dose series given by intramuscular injection on Day 1, Month 2, and Month 6. The study includes two cohorts: women aged 35 or older without or with mild cervical lesions (CIN 1/2) eligible for conservative treatment, and women aged 27 or older with multiple cervical, vulvar, or anal lesions also eligible for conservative treatment. All participants undergo vaccination and sample collection at four scheduled visits over about seven months. During the study, participants will provide cervical, anal, oral, and blood samples at Visits 1, 2, and 3 before vaccination and at Visit 4 after vaccination completion. Additional procedures include a urine pregnancy test at the first visit and completion of health and sexual activity questionnaires at Visits 1 and 4. Researchers will analyze viral infectivity using a cellular assay, measure antibody levels, detect HPV virions and DNA, and perform genotyping. The study's main outcome is the change in HPV infectivity before and after vaccination, with all monitoring and assessments completed within a seven-month period.

A Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV-Positive Women After Vaccination With 9vHPV (RIFT-HPV)