A Phase IV, open-label, single-arm, multicentric clinical trial for evaluation of Human Papillomavirus 9vHPV vaccine immunogenicity in Men Who Have Sex with Men living with HIV: GeSIDA Study 10017
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Background
Men who have sex with men (MSM) with HIV are at increased risk for anal cancer, largely attributable to persistent HPV infection. However, data on the nonavalent HPV vaccine (9vHPV) in MSM with HIV older than 26 remain sparse.
Methods
This phase IV trial evaluated the immunogenicity, safety, and impact of age and CD4/CD8 ratio on 9vHPV responses in MSM with HIV up to 35 years. Inclusion criteria were age 16–35, undetectable viral load, and CD4+ counts >200 cells/mm 3 . Participants received 9vHPV at weeks 0, 8, and 24, and were followed to week 96. Serum samples for immunogenicity, anal HPV DNA testing, and adverse event reports were collected at baseline, week 28, and week 96. Additionally, we investigated potential predictors of vaccine immunogenicity, including age group and CD4/CD8 ratio.
Results
Among 157 enrolled participants, 138 completed the per-protocol analysis. Seroconversion exceeded 85% for all nine HPV vaccine genotypes at week 96. New infections with vaccine-included genotypes occurred in 39.9% of participants, predominantly involving HPV-16. Clearance of existing HPV infections covered by the 9vHPV was 73.8%, and highest (≥80%) for HPV-18. Neither older age (≥26 years) nor lower CD4/CD8 ratio significantly reduced immunogenicity. No severe adverse events related to vaccination were recorded.
Conclusions
The 9vHPV vaccine demonstrated robust immunogenicity and encouraging viral clearance rates in MSM with HIV up to 35 years. These findings support extending vaccination beyond 26 years in this high-risk group, emphasizing the additional coverage provided by the 9vHPV formulation.
Clinical trial registration
EudraCT number 2018-000215-24.
Key points
9-valent HPV vaccination in MSM living with HIV up to 35 years shows good immunological response independent of age and CD4/CD8 value, with a good safety profile, suggesting benefit on incident infections and viral clearance.
