Vaccination Against Human Papillomavirus (HPV) With the 9-valent Vaccine in HIV-positive Women (the Papillon Study)

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

January 8, 2018

Primary Completion Date

May 2, 2023

Study Completion Date

May 2, 2028

Conditions
HPV - Anogenital Human Papilloma Virus InfectionHIV Infections
Interventions
BIOLOGICAL

Vaccine

All patients will receive the 9-valent vaccine against HPV (Gardasil9) intramuscularly: After a first open phase evaluating tolerability of Gardasil9, women will be randomized between two different doses schedules: in the first schedule, women will receive 2 doses at time 0 and 6 months and a third dose between 18-48 months if their antibody levels are insufficient; the second schedule will be 3 doses at 0, 2 and 6 months.

Trial Locations (1)

1000

Service de Maladies Infectieuses, CHU Saint-Pierre, Brussels

All Listed Sponsors
lead

Centre Hospitalier Universitaire Saint Pierre

OTHER