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

Hiv Clinical Trial

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

Clinical Trial 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 one HPV vaccination prior to HIV diagnosis.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06436274
Study type Interventional
Source Massachusetts General Hospital
Contact Diane Kanjilal, FNP
Phone 617-643-9958
Email IDCRU@mgh.harvard.edu
Status Not yet recruiting
Phase Phase 4
Start date September 2024
Completion date June 2027
View Details
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