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

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).

Conditions

Human Papilloma Virus, Anal Dysplasia, HIV

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Human Papilloma Virus
Intervention / Treatment

-

Contacts and Locations

Washington

RIIS Clinic at HIPS, Washington, District of Columbia, United States, 20002

Baltimore

RIIS Clinic at Baltimore Safe Haven, Baltimore, Maryland, United States, 21201

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Maryland, Baltimore,

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

Study Record Dates

2028-01