Evaluating the Gardasil HPV vaccine's immune responses in people with and without HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• RIIS Clinic at Baltimore Safe Haven
  Baltimore, Maryland, United States Recruiting
• RIIS Clinic at HIPS
  Washington D.C., District of Columbia, United States Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Project SHIELD 2.0: Police Education to Support Public Health in Kentucky

  Aimed at police in Kentucky, this program tests whether SHIELD training given to officers, with health workers helping deliver it, can reduce drug-related arrests and steer people who use drugs toward MOUD and other health services.

  Recruiting Johns Hopkins Bloomberg School of Public Health · Lexington, Kentucky · NCT07804121

• New ways to diagnose lymphoma and multicentric Castleman disease in people living with HIV

  This study tests a quick, point-of-care nucleic acid test to help diagnose lymphoma and multicentric Castleman disease in people living with HIV in sub-Saharan Africa.

  Recruiting Indiana University · Lilongwe · NCT07793006

• Bridge to Belonging: A Peer‑Led Program to Reduce Loneliness and Depression in older gay and bisexual men with HIV

  This program tests a peer-delivered, manualized approach to help men aged 50+ with HIV connect to LGBTQ+-affirming elder services to see if it reduces loneliness and depressive symptoms.

  Recruiting Fenway Community Health · Boston, Massachusetts · NCT07762066

• HIV vaccine test in healthy adults using CH505 nanoparticles and mRNA boosters

  This early-stage study will test the safety and immune responses of CH505 vaccine regimens in healthy adults to see if they can trigger HIV-specific immune protection.

  Recruiting at 2 sites Phase 1 National Institute of Allergy and Infectious Diseases (NIAID) · San Francisco, California and 7 other locations · NCT07757802

• Stigma-reducing program to help women who use drugs stay in HIV care

  This test checks whether a stigma-reduction program helps women living with HIV who use drugs stay engaged in HIV care in Ukraine.

  Recruiting Johns Hopkins Bloomberg School of Public Health · Kyiv, Kyiv Oblast · NCT07751978

• Platelets and HIV Reservoirs: A look at how platelets might harbor HIV in people living with HIV

  This observational study tests whether HIV can be found inside platelets in adults with suppressed HIV on therapy.

  Recruiting Tourcoing Hospital · Tourcoing · NCT07745530

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.