1-Year follow-up evaluation of TAK-003 dengue vaccine effectiveness against symptomatic disease and hospitalisation in adolescents during the 2024-2025 outbreak in São Paulo, Brazil: a test-negative case-control study.
case_control · Level III
Where this comes from
- Record sourced from PubMed, PMID 42729394.
- Also identified by DOI 10.1016/j.eclinm.2026.104181 and PMC identifier 13562391.
- Licence recorded as CC BY.
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Abstract
Dengue is a growing global health threat. Our initial evaluation of the TAK-003 dengue vaccine in adolescents during the 2024 outbreak in São Paulo State, Brazil, showed short-term protection but suggested possible effectiveness waning after 90-days of the first dose, and had limited power to estimate second-dose effectiveness against hospitalisation. We evaluated 1-year vaccine effectiveness against symptomatic, virologically confirmed dengue and dengue hospitalisation in adolescents during 2024-2025, when DENV-1 and DENV-2 predominated in 2024 followed by increasing DENV-3 transmission in 2025. We did a test-negative case-control study among adolescents aged 10-15 years in São Paulo State between Feb 20, 2024, and Dec 31, 2025. We extracted individual-level information on demographic characteristics, comorbidities, dengue testing, dengue vaccination, hospitalisation, and death during the study period from the national surveillance databases for dengue (SINAN-Dengue; compulsory notification) and the São Paulo State Secretary of Health vaccination registry (Rede Nacional de Dados em Saúde) on Feb 4, 2026. Cases were defined as acute febrile illness episodes with virologically confirmed dengue, as detected by NS1 antigen or RT-PCR testing within 5 days of symptom onset. Controls were test-negative acute febrile illness episodes. Surveillance data were linked to the state vaccination registry. Vaccine effectiveness after one or two TAK-003 doses was estimated with mixed-effects logistic regression. We analysed 166,390 tests: 65,365 from cases and 101,025 from controls. Vaccine effectiveness against symptomatic dengue was 59.2% (95% CI 56.1-62.0) after one dose and 73.1% (69.1-76.6) after two doses. Against dengue hospitalisation, effectiveness was 74.6% (62.7-82.7) after one dose and 87.9% (73.0-94.6) after two doses. One-dose protection against symptomatic disease showed no evidence of waning over 1-year follow-up: effectiveness was 73.8% (64.7-80.6) at 270-364 days and 76.8% (59.3-86.8) at 365 days or more. Two-dose protection remained stable to 1 year (74.6%, 95% CI 59.0-84.2, at 270-365 days). Findings were robust in sensitivity analyses and comparable during increased DENV-3 circulation. Our findings show that TAK-003 demonstrated sustained 1-year protection against symptomatic dengue and dengue hospitalisation in adolescents during a large outbreak. Notably, a single dose showed sustained effectiveness without evidence of waning over 1 year, generating an important hypothesis regarding dose reduction that warrants continued long-term observational evaluation. A second dose provided optimal protection, particularly against hospitalisation. These findings reinforce the importance of dengue vaccination as a public health measure. National Council for Scientific and Technological Development.