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Evaluating the Impact of Gardasil Nine-Valent Human Papilloma Virus Vaccine on Humoral and Cellular Immune Responses in Adults Born Male with or without HIV, PROTECT Trial
Trial Status: active
This phase II trial evaluates the impact of Gardasil nine-valent human papilloma virus (HPV) vaccine (Gardasil 9), copyright, on humoral and cellular immune response against HPV in adults born male with or without HIV. HPV is a virus that can cause genital warts, as well as cancer in the cervix, anus, and throat. Gardasil 9 is a vaccine that is FDA-approved for use in females and males aged 9 to 45 years to protect against infection with nine types of HPV. This vaccine is proven to protect from HPV and HPV-associated cancers (like anal cancer and cervical cancer). Currently, it is not known what the response to this vaccine is in adults. Giving Gardasil 9 may strengthen the immune system to protect against HPV infection in adults born male with or without HIV.
TEST GROUP: HIV-positive BM-EABE
* Living with HIV
* Current or past exposure to androgen blockers or estradiol
CONTROL GROUP: HIV-negative control
* HIV negative
* Either
** Current or past exposure to androgen blockers or estradiol
** OR 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)
Additional locations may be listed on ClinicalTrials.gov for NCT06624839.
Locations matching your search criteria
United States
District of Columbia
Washington
Research Initiative on Infectious Disease and Substance Use Research Clinic
I. To evaluate the immunogenicity of the nine-valent HPV recombinant vaccine and its impact on HPV humoral immunity in born male (BM)-exposure to androgen blockers or estrogen (EABE) with or without HIV.
SECONDARY OBJECTIVES:
I. Compare the humoral immune response to recombinant human papillomavirus nonavalent vaccine (Gardasil 9) between HIV positive BM-EABE and HIV negative controls.
II. Compare the humoral immune response to Gardasil 9 between BM-EABE (regardless of HIV status) and BM without EABE.
III. Evaluate the systemic HPV T-cell immune response to Gardasil 9 in HIV positive BM-EABE and HIV negative controls.
IV. Compare systemic HPV T-cell immune response to Gardasil 9 between HIV positive BM-EABE and HIV negative controls.
V. Compare systemic HPV T-cell immune response to Gardasil 9 between BM-EABE (regardless of HIV status) and BM without EABE.
VI. Evaluate the impact of HPV vaccination on HIV reservoir in CD4 T cells of BM-EABE with HIV.
VII. Compare humoral immune response to Gardasil 9 between different subset populations from PROTECT (HIV positive BM-EABE, HIV negative BM-EABE, and HIV negative men who have sex with a person with a penis [MSPP]), to age-matched historical controls.
EXPLORATORY OBJECTIVES:
I. Compare, pre-vaccine, the distribution of anal mucosal immune cells in HIV positive BM-EABE and HIV negative controls.
II. Evaluate the quantitative and qualitative mucosal T-cell response to Gardasil 9 in HIV positive BM-EABE and HIV negative controls.
III. Compare the quantitative and qualitative mucosal T-cell response to Gardasil 9 between BM-EABE (regardless of HIV status) and BM without EABE.
OUTLINE:
Patients receive Gardasil 9 intramuscularly (IM) on day 0 and on months 2 and 6. Patients also undergo blood and anal sample collection throughout the study. Patients with HPV16 and/or anal dysplasia on anal cytology receive referral for high resolution anoscopy (HRA) per standard of care.
After completion of study treatment, patients are followed up at 1 month. Optionally, patients with abnormal anal cytology and completed HRA are followed up monthly for 1-8 months following the last dose of the vaccine and following second HRA.
Trial PhasePhase II
Trial Typeprevention
Lead OrganizationUniversity of Maryland/Greenebaum Cancer Center
