NCT06436274

Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.

Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study.

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 778 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living with HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study is evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living with HIV who received prior HPV vaccination.

Detailed description

The HOPE II Study is an individual-level, randomized trial of immediate or delayed vaccination with a single-dose of the nonavalent HPV vaccine. The primary outcome is single-dose HPV 16/18/31/33/45/52/58 vaccine efficacy (VE). The study will provide evidence on the efficacy of single-dose HPV 16/18/31/33/45/52/58 vaccination among women living with HIV. Participants will be randomized 1:1 into two different Groups. * Group 1: Will receive nonavalent HPV vaccine at Day 0 and meningococcal vaccine at Month 18 * Group 2: Will receive the meningococcal vaccine at Day 0 and nonavalent HPV at Month 18 The meningococcal vaccine was chosen as the control vaccination because meningococcal vaccination has no activity against HPV infection. Further, the meningococcal vaccine has the potential to be of benefit in a meningitis outbreak context and could be beneficial for young persons in a congregate setting such as tertiary institutions.

Conditions

• Human Papilloma Virus
• Hiv

Interventions

Type	Name	Description
BIOLOGICAL	GARDASIL®9	GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines.
BIOLOGICAL	Menveo®/Menactra®	Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines.

Timeline

• Start date: 2024-10-14
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-05-31
• Last updated: 2026-01-12

Locations

3 sites across 3 countries: Botswana, Rwanda, South Africa