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Trial Title:
Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.
NCT ID:
NCT06436274
Condition:
Human Papilloma Virus
Hiv
Conditions: Official terms:
Papilloma
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
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.
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
GARDASIL®9
Description:
GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved
vaccines.
Arm group label:
Group 1
Arm group label:
Group 2
Intervention type:
Biological
Intervention name:
Menveo®/Menactra®
Description:
Menveo®/Menactra® or equivalent vaccines will be used for this study. These are
FDA-approved vaccines.
Arm group label:
Group 1
Arm group label:
Group 2
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
Assigned female at birth
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
University of Witwatersrand, South Africa
Agency class:
Other
Collaborator:
Agency:
Botswana Harvard AIDS Institute Partnership
Agency class:
Other
Collaborator:
Agency:
Ministry of Health, Rwanda
Agency class:
Other
Collaborator:
Agency:
Fred Hutchinson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06436274
