Human Papilloma VirusPhase 2PROTECTNCT06624839
Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
A Phase 2 study testing Human papillomavirus (HPV) vaccine, 9-valent in people with Human Papilloma Virus and Anal Dysplasia, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
This is a phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil9) in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, Anal Dysplasia, HIV
- What is being tested?
- Human papillomavirus (HPV) vaccine, 9-valent
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2025to Jan 2028
- Phase
- Phase 2
- 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 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older and 70 years old or younger
- Able to provide informed consent
- Denies history of prior HPV vaccination with Gardasil9 (receipt of HPV vaccination other than Gardasil9 such as the bivalent or the quadrivalent HPV vaccine will be allowed) or unsure of vaccination status and born before 2003
- Born Male
- For Test group: HIV-positive people born male with current or past exposure to androgen blockers or estrogen (BM-EABE)
- Living with HIV
Show all 10Show fewer
- Current or past exposure to androgen blockers or estradiol
- For Control group: HIV-negative Control
- HIV negative
- Either: Current or past exposure to androgen blockers or estradiol; no current or past exposure to androgen blockers or estradiol AND had sex with a person with a penis in the last year
Who cannot join
- Younger than 18 years old or older than 70 years old.
- Self-reported or documented history of nine-valent HPV vaccine or unsure of vaccination status and born after 2003.
- Born female
- History of hypersensitivity, including severe reactions to yeast or other component of the vaccine.
- Any condition requiring systemic chemotherapy or immunomodulant affecting antibody responses (i.e., rituximab, ibrutinib etc.), intravenous or subcutaneous immunoglobulin supplementation, radiation therapy, or immunomodulatory treatment within the previous 6 months (presence of precancerous lesions is not exclusionary).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
RIIS Clinic at Baltimore Safe Haven
Baltimore, Maryland, 21201
- Not yet recruiting
RIIS Clinic at HIPS
Washington D.C., District of Columbia, 20002
About this study
Official title: A PRe-pOsT Interventional Study Evaluating Gardasil Nine-valent Human Papilloma Virus (HPV) Vaccine Humoral and Cellular Immune Responses in People With or Without HIV
This is a phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil9) in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). Investigators will enroll BM-EABE with HIV and HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) and administer Gardasil9 at timepoints Day 0, Month 2, and Month 6. The immune response to the vaccine will be analyzed at Month 7 (1 month following the final vaccine dose).
Read the detailed description
This will be a phase 2, open-label study to assess the humoral and cellular immune response to the FDA-approved 9-valent HPV recombinant vaccine in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). At baseline, BM-EABE with HIV, HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) will provide blood samples and anal swabs for evaluation of HPV immunity, anal HPV and anal dysplasia. All participants will undergo a 3-dose vaccine series of the Gardasil vaccine (at Day 0, Month 2 and Month 6). Participants will then return one month after completion of third vaccine (Month 7) to provide repeat blood samples and anal swabs. Samples will be compared pre and post vaccination and in-between participants based on HIV and exposure to androgen blockers or estrogen (EABE).
Any participant with human papillomavirus 16 (HPV16) and/or anal dysplasia on anal cytology at any point will be referred to high-resolution anoscopy (HRA) for clinical management. Anal biopsies will be procured from different pathology laboratories - after clinical evaluation has been complete - for research analysis, including confocal microscopy. Those who had anal dysplasia at study entry will undergo repeat HRA, as clinically indicated, and will have an optional study visit following their repeat HRA to provide blood draw and anal swabs.
- Conditions
- Human Papilloma Virus, Anal Dysplasia, HIV
- Being tested
- Human papillomavirus (HPV) vaccine, 9-valent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human papillomavirus (HPV) vaccine, 9-valentBiological
Also called Gardasil9
0.5 ml intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| People born male with current or past exposure to androgen blockers or estrogen (BM-EABE) | Experimental | One dose of human papillomavirus (HPV) vaccine, 9-valent (Gardasil9) will be administered on Day 0, Month 2, and Month 6 Receives: Biological: Human papillomavirus (HPV) vaccine, 9-valent |
| HIV Negative BM-EABE or HIV Negative men who had sex with a person with a penis (MSPP) | Active comparator | One dose of human papillomavirus (HPV) vaccine, 9-valent (Gardasil9) will be administered on Day 0, Month 2, and Month 6 Receives: Biological: Human papillomavirus (HPV) vaccine, 9-valent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of the human papillomavirus (HPV) vaccine in BM-EABE (people born male with current or past exposure to androgen blockers or estrogen (BM-EABE) with and without HIV
Proportion of BM-EABE who become seropositive or have an increase in their GMT by >25% to at least 1 homologous HPV vaccine genotype at 1 month following the 3rd dose of the vaccine.
Measured: 7 months post 1st vaccine dose
Secondary outcomes (7)
Compare the humoral immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls
The difference between GMT titers against the 9-specific HPV types included in Gardasil between HIV positive BM-EABE and HIV negative controls.
Measured: 7 months post 1st vaccine dose
Compare the humoral immune response to Gardasil9 between BM-EABE (regardless of HIV status) and BM without EABE (people born male without current or past exposure to androgen blockers or estrogen)
The difference between GMT titers against the 9-specific HPV types included in Gardasil between BM-EABE and BM without EABE
Measured: 7 months post 1st vaccine dose
Evaluate the systemic HPV T-cell immune response to Gardasil9 in HIV positive BM-EABE and HIV negative controls.
A comprehensive assessment of HPV-specific T cell responses will be conducted with antigen stimulation of peripheral blood mononuclear cells (PBMCs) with virion-like protein (VLP) included in Gardasil 9. The proportion of proliferating T- cells, expressing activation-induced markers (AIM+) and IFN-gamma and TNF-alpha secreting T-cells will be evaluated by flow-cytometric assays; in addition the expression of exhaustion markers, perforin/granzyme B and skin- and gut-homing receptors, as well as the transcriptional analysis of T cells proliferating upon HPV antigenic stimulation will be assessed. This response will be assessed in HIV positive BM-EABE and HIV negative controls (BM-EABE and BM without EABE).
Measured: 7 months post 1st vaccine dose
Compare systemic HPV T-cell immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls.
The proportion of proliferating T- cells, expressing activation-induced markers (AIM+) and IFN-gamma and TNF-alpha secreting T-cells, the expression of exhaustion markers, perforin/granzyme B and skin- and gut-homing receptors and the transcriptional analysis of T cells proliferating upon HPV antigenic stimulation will be compared between: HIV positive BM-EABE and HIV negative controls; BM-EABE and BM without EABE
Measured: 7 months post 1st vaccine dose
Compare systemic HPV T-cell immune response to Gardasil9 between BM-EABE (regardless of HIV status) and BM without EABE.
The proportion of proliferating T- cells, expressing activation-induced markers (AIM+) and IFN-gamma and TNF-alpha secreting T-cells, the expression of exhaustion markers, perforin/granzyme B and skin- and gut-homing receptors and the transcriptional analysis of T cells proliferating upon HPV antigenic stimulation will be compared in BM-EABE and BM without EABE.
Measured: 7 months post 1st vaccine dose
Evaluate the impact of HPV vaccination on HIV reservoir in CD4 T cells of BM-EABE with HIV.
Distribution and density of mucosal immune cells (CD4+ and CD8+ T-cells, B/plasma cells, Dendritic/Langerhans cells, Natural killer (NK) cells, and macrophages) as seen on confocal microscopy from anal biopsies from HIV positive BM-EABE and HIV negative controls before Gardasil vaccination. Difference in distribution of mucosal immune cells as seen on confocal microscopy from anal biopsies after Gardasil.
Measured: Before vaccination, 7 months post 1st dose
Compare humoral immune response to Gardasil9 between different subset populations from PROTECT (HIV positive BM-EABE , HIV negative BM-EABE , and HIV negative MSPP), to age-matched historical controls.
The difference between GMT titers against the 9-specific HPV types included in Gardasil between subset of populations from PROTECT (HIV positive BM-EABE, HIV negative BM-EABE, men who have sex with a person with a penis (MSPP)) and historical controls from stored samples at the NIH
Measured: 7 months post 1st vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start15 Mar 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (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 University of Maryland, BaltimoreThe 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar Harfouch, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624839
- Sponsor's protocol ID
- HP-00109701
- Acronym
- PROTECT
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The principal investigator will share de-identified data with approved researchers at the time of publication or shortly afterwards.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PRe-pOsT Interventional Study Evaluating Gardasil Nine-valent Human Papilloma Virus (HPV) Vaccine Humoral and Cellular Immune Responses in People With or Without HIV
- ClinicalTrials.gov ID
- NCT06624839
- Acronym / sponsor ID
- PROTECT / HP-00109701
- Conditions
- Human Papilloma Virus, Anal Dysplasia, HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 3 Oct 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.
This is a phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil9) in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). Investigators will enroll BM-EABE with HIV and HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) and administer Gardasil9 at timepoints Day 0, Month 2, and Month 6. The immune response to the vaccine will be analyzed at Month 7 (1 month following the final vaccine dose).
Detailed description
This will be a phase 2, open-label study to assess the humoral and cellular immune response to the FDA-approved 9-valent HPV recombinant vaccine in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). At baseline, BM-EABE with HIV, HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) will provide blood samples and anal swabs for evaluation of HPV immunity, anal HPV and anal dysplasia. All participants will undergo a 3-dose vaccine series of the Gardasil vaccine (at Day 0, Month 2 and Month 6). Participants will then return one month after completion of third vaccine (Month 7) to provide repeat blood samples and anal swabs. Samples will be compared pre and post vaccination and in-between participants based on HIV and exposure to androgen blockers or estrogen (EABE).
Any participant with human papillomavirus 16 (HPV16) and/or anal dysplasia on anal cytology at any point will be referred to high-resolution anoscopy (HRA) for clinical management. Anal biopsies will be procured from different pathology laboratories - after clinical evaluation has been complete - for research analysis, including confocal microscopy. Those who had anal dysplasia at study entry will undergo repeat HRA, as clinically indicated, and will have an optional study visit following their repeat HRA to provide blood draw and anal swabs.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People born male with current or past exposure to androgen blockers or estrogen (BM-EABE) | Experimental | Biological: Human papillomavirus (HPV) vaccine, 9-valentOne dose of human papillomavirus (HPV) vaccine, 9-valent (Gardasil9) will be administered on Day 0, Month 2, and Month 6 |
| HIV Negative BM-EABE or HIV Negative men who had sex with a person with a penis (MSPP) | Active comparator | Biological: Human papillomavirus (HPV) vaccine, 9-valentOne dose of human papillomavirus (HPV) vaccine, 9-valent (Gardasil9) will be administered on Day 0, Month 2, and Month 6 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years old or older and 70 years old or younger
- Able to provide informed consent
- Denies history of prior HPV vaccination with Gardasil9 (receipt of HPV vaccination other than Gardasil9 such as the bivalent or the quadrivalent HPV vaccine will be allowed) or unsure of vaccination status and born before 2003
- Born Male
- For Test group: HIV-positive people born male with current or past exposure to androgen blockers or estrogen (BM-EABE)
Key exclusion criteria (5 listed)
- Younger than 18 years old or older than 70 years old.
- Self-reported or documented history of nine-valent HPV vaccine or unsure of vaccination status and born after 2003.
- Born female
- History of hypersensitivity, including severe reactions to yeast or other component of the vaccine.
- Any condition requiring systemic chemotherapy or immunomodulant affecting antibody responses (i.e., rituximab, ibrutinib etc.), intravenous or subcutaneous immunoglobulin supplementation, radiation therapy, or immunomodulatory treatment within the previous 6 months (presence of precancerous lesions is not exclusionary).
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 |
|---|---|---|
| Human papillomavirus (HPV) vaccine, 9-valentAlso: Gardasil90.5 ml intramuscular injection | Biological | HIV Negative BM-EABE or HIV Negative men who had sex with a person with a penis (MSPP), People born male with current or past exposure to androgen blockers or estrogen (BM-EABE) |
Primary outcome
Immunogenicity of the human papillomavirus (HPV) vaccine in BM-EABE (people born male with current or past exposure to androgen blockers or estrogen (BM-EABE) with and without HIV
Time frame: 7 months post 1st vaccine dose
Proportion of BM-EABE who become seropositive or have an increase in their GMT by >25% to at least 1 homologous HPV vaccine genotype at 1 month following the 3rd dose of the vaccine.
7 secondary outcomes
Compare the humoral immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls
Time frame: 7 months post 1st vaccine dose
Compare the humoral immune response to Gardasil9 between BM-EABE (regardless of HIV status) and BM without EABE (people born male without current or past exposure to androgen blockers or estrogen)
Time frame: 7 months post 1st vaccine dose
Evaluate the systemic HPV T-cell immune response to Gardasil9 in HIV positive BM-EABE and HIV negative controls.
Time frame: 7 months post 1st vaccine dose
Compare systemic HPV T-cell immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls.
Time frame: 7 months post 1st vaccine dose
Compare systemic HPV T-cell immune response to Gardasil9 between BM-EABE (regardless of HIV status) and BM without EABE.
Time frame: 7 months post 1st vaccine dose
Evaluate the impact of HPV vaccination on HIV reservoir in CD4 T cells of BM-EABE with HIV.
Time frame: Before vaccination, 7 months post 1st dose
Compare humoral immune response to Gardasil9 between different subset populations from PROTECT (HIV positive BM-EABE , HIV negative BM-EABE , and HIV negative MSPP), to age-matched historical controls.
Time frame: 7 months post 1st vaccine dose
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 5 Aug 2026.
- Individual participant dataSharing planned: Yes. The principal investigator will share de-identified data with approved researchers at the time of publication or shortly afterwards.
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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.
Omar Harfouch, MD principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human papillomavirus (HPV) vaccine, 9-valent in people with Human Papilloma Virus and Anal Dysplasia, run by University of Maryland, Baltimore at 2 sites in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Omar Harfouch, MD (410-706-1372, oharfouch@ihv.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity of the human papillomavirus (HPV) vaccine in BM-EABE (people born male with current or past exposure to androgen blockers or estrogen (BM-EABE) with and without HIV (time frame: 7 months post 1st vaccine dose). 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 5 Aug 2026.