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NOT YET RECRUITING
NCT07303751
PHASE2

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

Sponsor: Institut d'Investigació Biomèdica de Bellvitge

View on ClinicalTrials.gov

Summary

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.

Official title: HPV Vaccination and Infectivity Reduction in HPV-positive Women

Key Details

Gender

FEMALE

Age Range

18 Years - 29 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-02-01

Completion Date

2027-02-01

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

Nonavalent HPV vaccine (9vHPV)

Nonavalent HPV vaccine (9vHPV/ Gardasil-9™). Sterile suspension, 0.5 ml dose, intramuscular, prepared from the highly purified viruslike particles (VLPs) of the major capsid L1 protein from 9 HPV types: 6/11/16/18/31/33/45/52/58. 9vHPV is currently indicated in the EU in individuals from 9 years of age for the prevention of diseases caused by vaccine's 9 HPV types: genital warts (HPV6 and 11) and premalignant lesions and cancers affecting the cervix, vulva, vagina and anus (HPV16, 18, 31, 22, 45, 52 and 58). It was authorized for marketing in the EU on June 9th, 201

Locations (1)

Kambia Research Centre

Freetown, Sierra Leone