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

NCT06624839 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HP-00109701
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

  Proportion of BM-EABE who become seropositive or have an increase in their GMT by \>25% to at least 1 homologous HPV vaccine genotype at 1 month following the 3rd dose of the vaccine.

  7 months post 1st vaccine dose

Secondary Outcomes (7)

• Compare the humoral immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls

  7 months post 1st vaccine dose

• 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)

  7 months post 1st vaccine dose

• Evaluate the systemic HPV T-cell immune response to Gardasil9 in HIV positive BM-EABE and HIV negative controls.

  7 months post 1st vaccine dose

• Compare systemic HPV T-cell immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls.

  7 months post 1st vaccine dose

• Compare systemic HPV T-cell immune response to Gardasil9 between BM-EABE (regardless of HIV status) and BM without EABE.

  7 months post 1st vaccine dose

Study Arms (2)

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

EXPERIMENTAL

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

Biological: Human papillomavirus (HPV) vaccine, 9-valent

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

ACTIVE COMPARATOR

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

Biological: Human papillomavirus (HPV) vaccine, 9-valent

Interventions

Human papillomavirus (HPV) vaccine, 9-valent BIOLOGICAL

0.5 ml intramuscular injection

Also known as: Gardasil9

HIV Negative BM-EABE or HIV Negative men who had sex with a person with a penis (MSPP); People born male with current or past exposure to androgen blockers or estrogen (BM-EABE)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (2)

RIIS Clinic at HIPS

Washington D.C., District of Columbia, 20002, United States

NOT YET RECRUITING

RIIS Clinic at Baltimore Safe Haven

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Interventions

Papillomavirus Vaccines; Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Biological Products; Complex Mixtures

Study Officials

• Omar Harfouch, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Harfouch, MD

CONTACT

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

Onyinyechi Ogbumbadiugha-Weekes, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: October 3, 2024
• Study Start: March 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available at the time of publication or shortly following publication, and will be available indefinitely.
• Access Criteria: The criteria will be determined by the Principal Investigator

Locations

US (2)