Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well the Gardasil9 vaccine works in people born male who may have been exposed to certain hormone treatments, specifically those living with HIV and those who are HIV-negative. The goal is to see how the vaccine helps the immune system respond to the human papillomavirus (HPV), which can cause conditions like anal dysplasia, a type of abnormal cell growth. The study will involve giving participants the vaccine at three different times: right at the start, then two months later, and again at six months. Researchers will check the immune response one month after the last dose.

To participate, individuals must be between 18 and 70 years old, able to provide consent, and not have previously received the Gardasil9 vaccine. Those eligible for the study include men living with HIV who have had exposure to hormone treatments and HIV-negative men who have either had similar exposure or have had sex with someone with a penis in the last year. It’s important to note that the trial is not yet recruiting participants, so interested individuals will need to wait for the enrollment to begin.

Gender

MALE

Eligibility 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).