Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-70
SponsorUniversity of Maryland, Baltimore
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Human papillomavirus (HPV) vaccine, 9-valent
Biological/Vaccine0.5 ml intramuscular injection
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: People born male with current or past exposure to androgen blockers or estrogen (BM-EABE)Experimental treatment 1 intervention
Group B: HIV Negative BM-EABE or HIV Negative men who had sex with a person with a penis (MSPP)Active comparator 1 intervention
Trial outcomes
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.
Time frame
7 months post 1st vaccine doseSecondary outcomes
1
Compare the humoral immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls
The difference between GMT titers against the 9-specific HPV types included in Gardasil between HIV positive BM-EABE and HIV negative controls.
Time frame
7 months post 1st vaccine dose2
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)
The difference between GMT titers against the 9-specific HPV types included in Gardasil between BM-EABE and BM without EABE
Time frame
7 months post 1st vaccine dose3
Evaluate the systemic HPV T-cell immune response to Gardasil9 in HIV positive BM-EABE and HIV negative controls.
A comprehensive assessment of HPV-specific T cell responses will be conducted with antigen stimulation of peripheral blood mononuclear cells (PBMCs) with virion-like protein (VLP) included in Gardasil 9. The proportion of proliferating T- cells, expressing activation-induced markers (AIM+) and IFN-gamma and TNF-alpha secreting T-cells will be evaluated by flow-cytometric assays; in addition the expression of exhaustion markers, perforin/granzyme B and skin- and gut-homing receptors, as well as the transcriptional analysis of T cells proliferating upon HPV antigenic stimulation will be assessed. This response will be assessed in HIV positive BM-EABE and HIV negative controls (BM-EABE and BM without EABE).
Time frame
7 months post 1st vaccine dose4
Compare systemic HPV T-cell immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls.
The proportion of proliferating T- cells, expressing activation-induced markers (AIM+) and IFN-gamma and TNF-alpha secreting T-cells, the expression of exhaustion markers, perforin/granzyme B and skin- and gut-homing receptors and the transcriptional analysis of T cells proliferating upon HPV antigenic stimulation will be compared between: HIV positive BM-EABE and HIV negative controls; BM-EABE and BM without EABE
Time frame
7 months post 1st vaccine doseSponsors and contacts
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Source ClinicalTrials.gov