Data from 1,028 people vaccinated with TAK-003 in Catalonia suggest that the dengue vaccine has a good tolerability profile in routine clinical practice among travelers from areas where dengue is not endemic. The findings come from a study led by the Barcelona Institute for Global Health (ISGlobal), a center supported by the La Caixa Foundation and the Barcelona Hospital Clinic. Lancet Regional Health Europe. Follow-up of participants did not show any serious adverse events, but the reactions reported were mostly mild or moderate and less frequent after the second dose.
Dengue fever is a viral disease transmitted by the following viruses: Aedes mosquito. Infections have been recorded in more than 100 countries, and it is estimated that more than half of the world’s population lives in areas at risk of infection. In recent decades, the incidence of dengue fever has increased due to the geographic spread of mosquito vectors, which contributes to climate change, and increased international travel, which contributes to the global circulation of the virus. Dengue fever is also one of the leading causes of fever in people traveling to endemic areas. In this context, a safe dengue vaccine is essential to protect at-risk populations and inform effective public health strategies.
Evidence regarding vaccine safety in travelers is limited
TAK-003 is the first vaccine approved in Europe for prevention against dengue virus. However, data on safety in certain groups such as people who do not live in endemic areas, especially the elderly, people with pre-existing conditions, and people who have received additional vaccinations, remain limited.
“To address this knowledge gap, we conducted a pharmacovigilance study in eight travel health centers in Catalonia,” explains Daniel Campurbi Ferrer, lead author of the study, ISGlobal researcher and member of the Barcelona Hospital International Health Service. The study included 1,028 travelers (mostly adults) who received TAK-003 from January to December 2024. After each dose, participants were followed up to record any side effects.
We also wanted to assess whether factors such as age, gender, history of dengue infection, and coadministration of other vaccines were associated with an increased risk of local and systemic side effects. ”
Daniel Camprubi Ferrer, Barcelona Institute for Global Health
No serious adverse events were observed
The study recorded no serious adverse events after 1,851 doses of TAK-003. More than half of the participants reported some side effects, most of which were mild or moderate, temporary, and less frequent after the second dose. The most common symptoms were injection site pain, headache, fatigue, and general malaise.
Women and people with a history of dengue infection are more likely to experience side effects
The analysis found that female participants, those with a history of dengue infection, and those who were co-vaccinated with vaccines against other flaviviruses (such as yellow fever vaccine) were at higher risk of adverse events. In women, the reaction was mainly local, while in the other two groups it was mainly systemic, including fever.
“Importantly, we did not observe an increase in reactogenicity in people over 60 years of age or in people with comorbidities, two groups for which the evidence is very limited so far,” explains Cesc Bertrand Cobo, a researcher at ISGlobal and one of the study authors. The study also found that administering dengue vaccine concurrently with non-flaviviral vaccines did not increase the likelihood of adverse events, supporting the use of dengue vaccine in pre-travel consultations.
“Our findings expand the available evidence on the safety of TAK-003 in European travelers and highlight the need for continued evaluation of its impact, efficacy and long-term safety,” concludes José Muñoz, researcher at ISGlobal and Head of International Medical Services at Barcelona Hospital.
sauce:
Barcelona Institute of Global Health
Reference magazines:
Campurbi-Ferrer, D. others. (2026) Factors associated with the safety of dengue vaccine TAK-003 and adverse events in travelers from non-endemic areas: a real-world prospective multicenter pharmacovigilance cohort study in Spain. Lancet Community Health – Europe. DOI: 10.1016/j.lanepe.2026.101727. https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(26)00139-0/Full text.
