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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hiv; Human Papilloma Virus
• Intervention / Treatment: Biological: GARDASIL®9; Biological: Menveo®/Menactra®

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.

• Study Type: Interventional
• Enrollment (Actual): 778
• Phase: Phase 4

Contacts and Locations

Study Locations

• Botswana
  • Gaborone, Botswana, 0000
    • Botswana Harvard Health Partnership
• Rwanda
  • Kigali
    • Kigali, Kigali, Rwanda, +250
      • Ministry of Health and Center for Family Health Research
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2001
      • Wits RHI, University of the Witwatersrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18	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.
Active Comparator: Group 2; Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 Months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI); Karolinska Institutet; Fred Hutchinson Cancer Center; University of Witwatersrand, South Africa; Ministry of Health, Rwanda; Botswana Harvard Health Partnership
• Investigators: Principal Investigator: Sinead Delany-Moretlwe, MBBCh, PhD, DTM&H, Wits RHI, University of the Witwatersrand; Principal Investigator: Ruanne Barnabas, MBChB, MSc, DPhil, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 2024P000880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No