Recruiting
Phase 2

Gardasil9

Sponsor:

University of Maryland, Baltimore

Code:

NCT06624839

Conditions

Human Papilloma Virus

Anal Dysplasia

HIV

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Human papillomavirus (HPV) vaccine, 9-valent

Study Details

Brief 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). 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).

Conditions

Human Papilloma Virus

Anal Dysplasia

HIV

Study ID

NCT06624839

Start date

Mar 15, 2025

Status verified date

Aug, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: People born male with current or past exposure to androgen blockers or estrogen (BM-EABE)

One dose of human papillomavirus (HPV) vaccine, 9-valent (Gardasil9) will be administered on Day 0, Month 2, and Month 6

active comparator: HIV Negative BM-EABE or HIV Negative men who had sex with a person with a penis (MSPP)

One dose of human papillomavirus (HPV) vaccine, 9-valent (Gardasil9) will be administered on Day 0, Month 2, and Month 6

Interventions

Human papillomavirus (HPV) vaccine, 9-valent

0.5 ml intramuscular injection

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 ]

Central Contacts and Locations

Central contacts

Omar Harfouch, MD

410-706-1372oharfouch@ihv.umaryland.edu

Onyinyechi Ogbumbadiugha-Weekes, MPH

443-635-4943oogbumbadiugha@ihv.umaryland.edu

Locations

RIIS Clinic at Baltimore Safe Haven

Recruiting

Baltimore, Maryland, United States, 21201

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-08-05.