The primary objective of this study is to determine the magnitude and breadth of the serum antibody response to the nonavalent HPV vaccine (Gardasil-9) in adults with well-controlled HIV infection.
The secondary objectives of the study are to observe short term clinical outcomes of prevalent HPV genotype-specific anogenital infections in adults living with HIV who complete the three-dose Gardasil-9 vaccine series, and to determine the protection afforded by Gardasil vaccine over time in previously vaccinated adults living with HIV.
The clinical hypothesis is that adults with virologically controlled HIV mount a serum antibody response to the nonavalent HPV vaccine that is comparable to HIV negative counterparts. We also postulate that HPV vaccination will provide short-term clinical benefit against HPV infections and disease associated with vaccine genotypes and continuing protection against vaccine genotypes of HPV over time.
HIV seropositive
immune intact (CD4+ T cell count in peripheral blood >200 cells/ml)
HIV controlled (peripheral blood HIV viral load <1,000 genome copies/mL)
Stable on antiretroviral regimen for ≥3 months
Medical contraindication for vaccination (vaccine-naive arm only)
Women who are pregnant
Acute illness
Taking chronic steroids, >0.5mg/kg prednisone or equivalent
Single group
Human papillomavirus 9-valent vaccine, recombinant
Biological/VaccineSubunit vaccine against 9 genotypes of human papillomavirus (6, 11, 16, 18, 31, 33, 45, 52, 58)
human papillomavirus vaccine, recombinant
Biological/VaccineSubunit vaccine against four (6, 11, 16, 18) or nine (6, 11, 16, 18, 31, 33, 45, 52, 58) genotypes of human papillomavirus. Administered as part of participant's clinical care prior to study enrollment (intervention not delivered as part of study design).
change in serological response to Gardasil-9
serum antibodies against human papillomavirus genotypes 6,11,16,18,31,33,45,52, and 58
serum antibody titers in vaccine-experienced cohort
serum antibody titers against Gardasil-9 vaccine HPV genotypes in cohort of individuals with prior vaccine history, compared to time-since-vaccine completion
change in HPV infection status: resolution of prevalent HPV infection
time-to-clearance of prevalent HPV infection of the oral cavity, vaginal tract and/or anal canal
change in HPV infection status: protection against incident HPV infection
acquisition of genotype-specific HPV infection following Gardasil-9 immunization at mucosal sites (oral cavity, genital tract, anal canal)
HPV prevalence in vaccine experienced cohort
Prevalence of mucosal (oral, cervical, and anal) HPV detection by genotype in individuals with prior Gardasil vaccine experience.
change in mucosal antibody response to Gardasil-9
HPV-16 antibodies in saliva
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Louisiana State University Health Sciences Center in New Orleans
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
