TAK-003 Dengue Vaccine Administration in People with HIV, an Observational Study.

With its rising incidence, dengue is a growing global health concern. This retrospective observational study evaluated short-term safety of the dengue vaccine TAK-003 in people with asymptomatic HIV infection and no evidence of impaired immune function that have received at least one dose of TAK-003 at the Travel Medicine Clinic of the Infectious Diseases Unit of San Raffaele Scientific Institute, Milan, Italy, from January 2024 to December 2025. Globally, 12/20 (60%) participants did not report any adverse event after both doses. Seven (35%) experienced mild general or local disorders after dose 1, one reported local disorders after D2. In each case, adverse events resolved spontaneously after 1-3 days. No severe AEs were reported. HIVRNA, CD4+ count and percentage did not significantly vary after both doses of TAK-003. TAK-003 was well tolerated, with adverse events being generally mild, self-limiting and comparable to those observed in the general population. Individuals of ≥60 years of age did not report any adverse events. No significant changes in HIVRNA, CD4+ count and percentage were observed after vaccination.