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NCT Number: NCT06436274

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Human Papilloma Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Botswana Harvard Health Partnership, Gaborone, Botswana

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

GARDASIL®9

Biological

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.

Primary outcomes

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

    Time frame: 18 Months

    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.

Secondary outcomes

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

    Time frame: 18 Months

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HOPE II

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 31, 2024
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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