RECRUITING

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

Conditions

Human Papilloma Virus Anal Dysplasia HIV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2025-03-15

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06624839

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * Living with HIV * Current or past exposure to androgen blockers or estradiol * 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	* 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).

Inclusion Criteria

Exclusion 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
* Living with HIV
* Current or past exposure to androgen blockers or estradiol
* 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

* 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).

Contacts and Locations

Study Contact

Omar Harfouch, MD

CONTACT

410-706-1372

oharfouch@ihv.umaryland.edu

Onyinyechi Ogbumbadiugha-Weekes, MPH

CONTACT

443-635-4943

oogbumbadiugha@ihv.umaryland.edu

Principal Investigator

Omar Harfouch, MD

PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Study Locations (Sites)

RIIS Clinic at HIPS

Washington, District of Columbia, 20002

United States

RIIS Clinic at Baltimore Safe Haven

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Omar Harfouch, MD, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-15

Study Completion Date2028-01

Study Record Updates

Study Start Date2025-03-15

Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

Human Papilloma Virus
Anal Dysplasia
HIV