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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

778 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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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

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Human Papilloma Virus Hiv

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18

Group Type EXPERIMENTAL

GARDASIL®9

Intervention Type BIOLOGICAL

GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines.

Menveo®/Menactra®

Intervention Type BIOLOGICAL

Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines.

Group 2

Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18

Group Type ACTIVE_COMPARATOR

GARDASIL®9

Intervention Type BIOLOGICAL

GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines.

Menveo®/Menactra®

Intervention Type BIOLOGICAL

Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines.

Interventions

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GARDASIL®9

GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines.

Intervention Type BIOLOGICAL

Menveo®/Menactra®

Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Age 16 years and above on the day of signing the ICF
2. Living with HIV with confirmed test results or clinic records
3. History of receiving HPV vaccine
4. Self-reported sexually active in the last six months
5. Lives within the study area and willing to provide updated locator information over the course of the study
6. Does not have an autoimmune, degenerative, or genetic disease
7. Does not have known advanced HIV (as per stage IV WHO clinical staging criteria for HIV)
8. No other Investigator-determined factor would limit participation in the trial
9. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study
10. The participant has a cervix