Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV

This is a randomized, open-label trial, to assess whether a single dose of HPV nonavalent vaccine, administered to HIV uninfected, unvaccinated women with high risk HPV16/18/31/33/45/52 or 58 can decrease the infectivity of shed HPV viruses. Our hypothesis is that vaccination will have little or no impact on HPV sample positivity by DNA PCR since the viral particles will continue to be produced and released, but that particles will be neutralized by vaccine-induced antibodies, thereby reducing their infective capacity. Cervical samples will be collected at randomisation and at 6 months, to compare infectivity of shed HPV viruses.

NCT Number	NCT07303751
Lead Sponsor	Institut d'Investigació Biomèdica de Bellvitge
Conditions	HPV, High-risk HPV (Any Strain), Human Papillomavirus (HPV) Infections
Enrollment	80 participants
Start Date	2026-02-01
Primary Completion	2027-02-01 (estimated)
Study Completion	2027-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-11