Human Papilloma VirusPhase 4HOPE IINCT06436274
Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.
A Phase 4 study testing GARDASIL®9 and Menveo®/Menactra® in people with Human Papilloma Virus and Hiv, run by Massachusetts General Hospital at 3 sites in 3 countries.
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 prior HPV vaccination. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Human Papilloma Virus, Hiv
- What is being tested?
- GARDASIL®9 and Menveo®/Menactra®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 778 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 14 Oct 2024to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Anyone with cervical abnormality on examination
- Anyone with an allergy to vaccine components or yeast
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Rwanda1 site
Ministry of Health and Center for Family Health Research
Kigali, Kigali, +250
South Africa1 site
Wits RHI, University of the Witwatersrand
Johannesburg, Gauteng, 2001
About this study
Official title: Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study.
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.
Read the 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.
- Conditions
- Human Papilloma Virus, Hiv
- Being tested
- GARDASIL®9, Menveo®/Menactra®
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GARDASIL®9Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18 Receives: 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 Receives: Biological: GARDASIL®9; Biological: Menveo®/Menactra® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 Months
Secondary outcomes (1)
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.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start14 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 778 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Botswana Harvard Health Partnership, Ministry of Health, Rwanda, Fred Hutchinson Cancer Center, National Cancer Institute (NCI), Karolinska Institutet
- Responsible party
- Principal investigator, Ruanne Barnabas, MBChB, MSc, DPhil., Massachusetts General Hospital
- Investigators
- Ruanne Barnabas, MBChB, MSc, DPhil, Principal investigator, Massachusetts General HospitalSinead Delany-Moretlwe, MBBCh, PhD, DTM&H, Principal investigator, Wits RHI, University of The Witwatersrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436274
- Sponsor's protocol ID
- 2024P000880
- Acronym
- HOPE II
- Status last verified
- Jan 2026
- First submitted
- 24 May 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06436274
- Acronym / sponsor ID
- HOPE II / 2024P000880
- Conditions
- Human Papilloma Virus, Hiv
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 778 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, Botswana Harvard Health Partnership, Ministry of Health, Rwanda, Fred Hutchinson Cancer Center, National Cancer Institute (NCI), Karolinska Institutet
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: GARDASIL®9, Biological: Menveo®/Menactra®Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18 |
| Group 2 | Active comparator | Biological: GARDASIL®9, Biological: Menveo®/Menactra®Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18 |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- Anyone with cervical abnormality on examination
- Anyone with an allergy to vaccine components or yeast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GARDASIL®9GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines. | Biological | Group 1, Group 2 |
| Menveo®/Menactra®Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines. | Biological | Group 1, Group 2 |
Primary outcome
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.
1 secondary outcome
Safety and tolerability of single-dose nonavalent HPV vaccination in women living with HIV.
Time frame: 18 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Human Papilloma Virus
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruanne Barnabas, MBChB, MSc, DPhil principal investigator
Massachusetts General Hospital
Sinead Delany-Moretlwe, MBBCh, PhD, DTM&H principal investigator
Wits RHI, University of The Witwatersrand
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GARDASIL®9 and Menveo®/Menactra® in people with Human Papilloma Virus and Hiv, run by Massachusetts General Hospital at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Botswana, Rwanda, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of single-dose HPV among women living with HIV who were vaccinated against HPV 16/18. (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.