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

Phase 4Active Not RecruitingNCT06436274

Massachusetts General Hospital778 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

778

Conditions

Human Papilloma Virus Hiv

Interventions

GARDASIL®9BIOLOGICAL

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

Menveo®/Menactra®BIOLOGICAL

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

Eligibility

Sex: FEMALEMin age: 16 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: 1. Anyone with cervical abnormality on examination 2. Anyone with an allergy to vaccine components or yeast

Locations (3)

Botswana Harvard Health Partnership

Gaborone, Botswana

Ministry of Health and Center for Family Health Research

Kigali, Kigali, Rwanda

Wits RHI, University of the Witwatersrand

Johannesburg, Gauteng, South Africa

Outcomes

Primary Outcomes

Efficacy of single-dose HPV among women living with HIV who were vaccinated against HPV 16/18.

Efficacy will be measured by the incidence of persistent infection from at least one of these HPV 16/18/31/33/45/52/58, where persistence is defined as a positive test at two consecutive visits at least 4.5 months apart.

Time frame: 18 Months

Secondary Outcomes

Safety and tolerability of single-dose nonavalent HPV vaccination in women living with HIV.

This will be evaluated by comparing the occurrence of serious adverse events reported among each study arm.

Time frame: 18 Months

Data from ClinicalTrials.gov

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