A Phase 4 interventional study of GARDASIL®9 and Menveo®/Menactra® in Human Papilloma Virus and Hiv, sponsored by Massachusetts General Hospital. Active, not recruiting at 3 sites in 3 countries. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Prevention
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.
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.
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 778 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18
Biological: GARDASIL®9 · Biological: Menveo®/Menactra®
Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18
Biological: GARDASIL®9 · Biological: Menveo®/Menactra®
GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines.
Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines.
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.
Time frame: 18 Months
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.
Time frame: 18 Months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2026, 26 months after the start.
Of 64 non-industry phase 4 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 49. This study's planned 26 months is below that.
Counting every sponsor, half of 70 studies reached it within 31 months; a quarter within 22 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Human Papillomavirus Recombinant Vaccine nonavalent
Acquired Immunodeficiency Syndrome →
Massachusetts General Hospital →