Evaluating the Gardasil HPV vaccine's immune responses in people with and without HIV
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 study is testing how well the Gardasil HPV vaccine works in people born male, both with and without HIV, to see how their immune systems respond to the vaccine.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | rituximab, ibrutinib, chemotherapy, radiation |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT06624839 on ClinicalTrials.gov |
What this trial studies
This phase 2, open-label study aims to assess the immune response to the 9-valent HPV vaccine (Gardasil9) in individuals born male who have either HIV or are HIV-negative. Participants will receive the vaccine at three time points: Day 0, Month 2, and Month 6, with immune responses evaluated one month after the final dose. Blood samples and anal swabs will be collected to analyze HPV immunity and anal dysplasia, comparing results between those with and without HIV and those with exposure to androgen blockers or estrogen. The study will also refer participants with HPV16 or anal dysplasia for further clinical management.
Who should consider this trial
Good fit: Ideal candidates include individuals born male aged 18 to 70, with either HIV or those who are HIV-negative and have had exposure to androgen blockers or estrogen.
Not a fit: Patients who are younger than 18 or older than 70, or those who have a history of receiving the Gardasil9 vaccine, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of HPV vaccine efficacy in diverse populations, potentially leading to improved prevention strategies for HPV-related diseases.
How similar studies have performed: Other studies have shown promising results in evaluating HPV vaccine responses in various populations, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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).
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- RIIS Clinic at HIPS — Washington D.C., District of Columbia, United States (Not_yet_recruiting)
- RIIS Clinic at Baltimore Safe Haven — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Omar Harfouch, MD — University of Maryland, Baltimore
- Study coordinator: Omar Harfouch, MD
- Email: oharfouch@ihv.umaryland.edu
- Phone: 410-706-1372
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.