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Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in People Living With Adequately Managed HIV (AGO-Gard)
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.
Details
| Lead sponsor | Louisiana State University Health Sciences Center in New Orleans |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 250 |
| Start date | 2022-11-30 |
| Completion | 2026-06 |
Conditions
- Papillomavirus Vaccines
- Human Immunodeficiency Virus
- Papillomavirus Infection
- Serology
- Cervical Intraepithelial Neoplasia
- Anal Intraepithelial Neoplasia
- Oral Cavity Infection
Interventions
- Human papillomavirus 9-valent vaccine, recombinant
- human papillomavirus vaccine, recombinant
Primary outcomes
- change in serological response to Gardasil-9 — 18 months
serum antibodies against human papillomavirus genotypes 6,11,16,18,31,33,45,52, and 58 - serum antibody titers in vaccine-experienced cohort — Variable time-since-vaccine completion. Single time-point evaluation.
serum antibody titers against Gardasil-9 vaccine HPV genotypes in cohort of individuals with prior vaccine history, compared to time-since-vaccine completion
Countries
United States