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Trial Title:
Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in Sexual and Gender minoriTies
NCT ID:
NCT06624839
Condition:
Transgender Persons
Human Papilloma Virus
Anal Dysplasia
Conditions: Official terms:
Papilloma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Human papillomavirus (HPV) vaccine, 9-valent
Description:
0.5 ml intramuscular injection
Arm group label:
HIV Negative Assigned Male at Birth (AMAB)
Arm group label:
HIV positive Transgender persons assigned male at birth (TG-AMAB)
Other name:
Gardasil9
Summary:
This is a phase 2, open-label study to assess the immunogenicity of the 9-valent human
papillomavirus (HPV) recombinant vaccine (Gardasil9) in transgender women (TGW).
Investigators will enroll human immunodeficiency virus (HIV) positive transgender persons
assigned male at birth (TG-AMAB) and HIV negative controls 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 transgender persons
assigned male at birth (TG-AMAB). At baseline, TG-AMAB with HIV and HIV negative assigned
male at birth (AMAB) controls 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 gender affirming hormone therapy (GAHT) status.
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.
Criteria for 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 or unsure of vaccination
status and born before 2003
- Assigned male at birth.
For Test group: HIV-positive transgender persons assigned male at birth (TG-AMAB)
- Living with HIV
- Gender identity different from sex assigned at birth (ie woman, transgender,
non-binary, two-spirit, gender diverse, genderqueer)
For Control group: HIV-negative Control
- HIV negative
- Either: Gender identity different from sex assigned at birth (regardless of sexual
activity) or cisgender man 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.
- Assigned a sex other than male at birth.
- 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).
Gender:
Male
Gender based:
Yes
Gender description:
Transgender persons assigned male at birth, cisgender men
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
October 2024
Completion date:
January 2028
Lead sponsor:
Agency:
University of Maryland, Baltimore
Agency class:
Other
Source:
University of Maryland, Baltimore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06624839
