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

NCT06436274 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2024P000880
• Study Type: interventional
• Target: 778
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Human Papilloma Virus; Hiv

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  18 Months

Study Arms (2)

Group 1

EXPERIMENTAL

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

Biological: GARDASIL®9; Biological: Menveo®/Menactra®

Group 2

ACTIVE COMPARATOR

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

Biological: GARDASIL®9; Biological: Menveo®/Menactra®

Interventions

GARDASIL®9 BIOLOGICAL

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

Group 1; Group 2

Menveo®/Menactra® BIOLOGICAL

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

Group 1; Group 2

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Assigned female at birth
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Anyone with cervical abnormality on examination
• Anyone with an allergy to vaccine components or yeast

Sponsors & Collaborators

• Botswana Harvard Health Partnership: collaborator
• Ministry of Health, Rwanda: collaborator
• Fred Hutchinson Cancer Center: collaborator
• National Cancer Institute (NCI): collaborator
• Karolinska Institutet: collaborator
• Massachusetts General Hospital: lead
• University of Witwatersrand, South Africa: collaborator

Study Sites (3)

Botswana Harvard Health Partnership

Gaborone, 0000, Botswana

Location

Ministry of Health and Center for Family Health Research

Kigali, Kigali, +250, Rwanda

Location

Wits RHI, University of the Witwatersrand

Johannesburg, Gauteng, 2001, South Africa

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Ruanne Barnabas, MBChB, MSc, DPhil

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Sinead Delany-Moretlwe, MBBCh, PhD, DTM&H

  Wits RHI, University of The Witwatersrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Division of Infectious Diseases

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1); ZA (1); RW (1)