Clinical trial NCT06624839: Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Human Papilloma Virus
Anal Dysplasia
HIV
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Detailed description: This will be a phase 2, open-label study to assess the humoral and cellular immune response to the FDA-approved 9-valent HPV recombinant vaccine in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). At baseline, BM-EABE with HIV, HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) will provide blood samples and anal swabs for evaluation of HPV immunity, anal HPV and anal dysplasia. All participants will undergo a 3-dose vaccine series of the Gardasil vaccine (at Day 0, Month 2 and Month 6). Participants will then return one month after completion of third vaccine (Month 7) to provide repeat blood samples and anal swabs. Samples will be compared pre and post vaccination and in-between participants based on HIV and exposure to androgen blockers or estrogen (EABE).

Any participant with human papillomavirus 16 (HPV16) and/or anal dysplasia on anal cytology at any point will be referred to high-resolution anoscopy (HRA) for clinical management. Anal biopsies will be procured from different pathology laboratories - after clinical evaluation has been complete - for research analysis, including confocal microscopy. Those who had anal dysplasia at study entry will undergo repeat HRA, as clinically indicated, and will have an optional study visit following their repeat HRA to provide blood draw and anal swabs.

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).

Primary outcomes:
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
timeFrame: 7 months post 1st vaccine dose
Secondary outcomes:
measure: Compare the humoral immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls
timeFrame: 7 months post 1st vaccine dose
measure: Compare the humoral immune response to Gardasil9 between BM-EABE (regardless of HIV status) and BM without EABE (people born male without current or past exposure to androgen blockers or estrogen)
timeFrame: 7 months post 1st vaccine dose
measure: Evaluate the systemic HPV T-cell immune response to Gardasil9 in HIV positive BM-EABE and HIV negative controls.
timeFrame: 7 months post 1st vaccine dose
measure: Compare systemic HPV T-cell immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls.
timeFrame: 7 months post 1st vaccine dose
measure: Compare systemic HPV T-cell immune response to Gardasil9 between BM-EABE (regardless of HIV status) and BM without EABE.
timeFrame: 7 months post 1st vaccine dose
measure: Evaluate the impact of HPV vaccination on HIV reservoir in CD4 T cells of BM-EABE with HIV.
timeFrame: Before vaccination, 7 months post 1st dose
measure: Compare humoral immune response to Gardasil9 between different subset populations from PROTECT (HIV positive BM-EABE , HIV negative BM-EABE , and HIV negative MSPP), to age-matched historical controls.
timeFrame: 7 months post 1st vaccine dose
Other outcomes:
Locations:
city: Washington
country: United States
facility: RIIS Clinic at HIPS
state: District of Columbia
city: Baltimore
country: United States
facility: RIIS Clinic at Baltimore Safe Haven
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Omar Harfouch, MD
role: PRINCIPAL_INVESTIGATOR
References: