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

Hiv Clinical Trial

— HOPE II  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436274
• Other study ID #: 2024P000880
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2024
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Diane Kanjilal, FNP
• Phone: 617-643-9958
• Email: IDCRU[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 one HPV vaccination prior to HIV diagnosis.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: June 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Assigned female at birth

2. Age 16 years and above on the day of signing the informed consent form

3. Living with HIV with confirmed test results or clinic records

4. History of receiving a single dose of an HPV vaccine before HIV diagnosis

5. Self-reported sexually active in the last six months

6. Lives within the study area and willing to provide updated locator information over the course of the study

7. Does not have an autoimmune, degenerative, or genetic disease

8. Does not have known advanced HIV (as per stage IV World Health Organization clinical staging criteria for HIV)

9. No other Investigator-determined factor would limit participation in the trial

10. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study

11. The participant has a cervix

Exclusion Criteria:

1. Anyone with cervical abnormality on examination

2. Anyone with an allergy to vaccine components or yeast

Related Conditions & MeSH terms

• Hiv
• Human Papilloma Virus
• Papilloma

Intervention

Biological:
• GARDASIL®9
GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines.
• Menveo®/Menactra®
Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Botswana Harvard AIDS Institute Partnership, Fred Hutchinson Cancer Center, Ministry of Health, Rwanda, National Cancer Institute (NCI), University of Witwatersrand, South Africa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of single-dose HPV among women living with HIV who were vaccinated against HPV 16/18 before their HIV diagnosis.	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	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