Key Finding: No serious adverse events were reported after 1,851 doses of the TAK-003 dengue vaccine.
A study published in The Lancet Regional Health Europe assessed the safety of the dengue vaccine TAK-003 in 1,028 travelers from non-endemic regions. The research, conducted by the Barcelona Institute for Global Health (ISGlobal) and Hospital Clínic Barcelona, took place from January to December 2024 across eight travel health centers in Catalonia, Spain.
Key Findings
- No serious adverse events were reported after 1,851 doses.
- Over half of participants reported mild or moderate adverse effects, which were temporary and less frequent after the second dose.
- Common symptoms included injection site pain, headache, fatigue, and general malaise.
- Female participants, individuals with prior dengue infection, and those who received concurrent flavivirus vaccines (e.g., yellow fever vaccine) had a higher risk of adverse events.
- No increased reactogenicity was observed in people over 60 years old or those with comorbidities.
- Co-administration with non-flaviviral vaccines did not increase adverse event likelihood.
Background
Dengue is a viral disease transmitted by Aedes mosquitoes, endemic in over 100 countries. TAK-003 is the first dengue vaccine authorized in Europe, but data on its safety in non-endemic travelers were limited, especially for older adults and those with pre-existing conditions.
Study Details
The prospective pharmacovigilance cohort study included mostly adult travelers. Factors such as age, sex, prior dengue infection, and co-administration of other vaccines were analyzed for association with adverse effects.