Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Human papillomavirus (HPV) vaccine, 9-valent.
- Who it may be relevant to
- Registry conditions: Human Papilloma Virus, Anal Dysplasia, HIV. Basic parameters: 18 years — 70 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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).
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.
Interventions
- Biological Human papillomavirus (HPV) vaccine, 9-valent
0.5 ml intramuscular injection
Primary outcome measures
- 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 [Time frame: 7 months post 1st vaccine dose]
Secondary outcome measures (7)
- Compare the humoral immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls [Time frame: 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) [Time frame: 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. [Time frame: 7 months post 1st vaccine dose]
- Compare systemic HPV T-cell immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls. [Time frame: 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. [Time frame: 7 months post 1st vaccine dose]
- Evaluate the impact of HPV vaccination on HIV reservoir in CD4 T cells of BM-EABE with HIV. [Time frame: Before vaccination, 7 months post 1st dose]
- 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. [Time frame: 7 months post 1st vaccine dose]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- RIIS Clinic at HIPS — Washington D.C.
- RIIS Clinic at Baltimore Safe Haven — Baltimore
Identifiers
NCT: NCT06624839 · HP-00109701