Trial reportThe Journal of infectious diseases2025
Estimated Efficacy of TAK-003 Against Asymptomatic Dengue Infection in Children and Adolescents Participating in the DEN-301 Trial in Asia Pacific and Latin America.
Trial report in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02747927 (Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine), which is not on this map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 - 16 Years Old
Who cites it
5 citing papers in PubMed.
- Mapping immune responses to TAK-003 dengue vaccine: immunogenicity across the clinical development program.Frontiers in immunology · 2026Review
- Update on efficacy, safety, and immunogenicity of Dengue vaccines: a systematic review and meta-analysis.Le infezioni in medicina · 2026Review
- Efficacy, public health impact and optimal use of the Takeda dengue vaccine.Nature medicine · 2025Article
- Review
- The urgent need for a licensed dengue vaccine in the Philippines.Therapeutic advances in vaccines and immunotherapy · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundTAK-003 has been shown to be well tolerated and effective against symptomatic dengue disease and hospitalization, irrespective of baseline serostatus. Most infections are asymptomatic/subclinical. This study assessed whether TAK-003 could protect against asymptomatic/subclinical infections by evaluating increased neutralizing antibody (NAb) titers after natural infection.
methodsDEN-301 (NCT02747927) is a phase 3 trial among 4- to 16-year-old participants who received 2 doses of TAK-003 or placebo 3 months apart. These exploratory analyses used NAb measured during the trial. As no well-accepted definition for asymptomatic infection exists, 3 algorithms were evaluated: (1) 4-fold increase in NAb, (2) 4-fold increase in NAb and a minimum titer of 40, and (3) 4-fold increase in NAb and a minimum titer of 4-fold lower limit of quantification. Months 4 to 9, months 9 to 15, and months 15 to 27 after first vaccination were analyzed.
resultsNAbs from 3765 participants were analyzed. From months 4 to 9, vaccine efficacy (VE) against asymptomatic infection was 51.1% (95% CI, 30.4%-65.6%), 36.1% (95% CI, 6.7%-56.3%), and 27.3% (95% CI, -8.2% to 51.2%) for algorithms 1, 2, and 3, respectively. VE per algorithms 1, 2, and 3 was 54.8% (95% CI, 28.8%-71.3%), 47.9% (95% CI, 16.8%-67.4%), and 44.3% (95% CI, 9.9%-65.6%) in participants with baseline seropositivity and 44.4% (95% CI, 2.1%-68.4%), 4.6% (95% CI, -85.1% to 50.8%), and -29.3% (95% CI, -172.1% to 38.6%) in those with baseline seronegativity. VE against asymptomatic infection gradually decreased from months 4 to 9 to months 9 to 15 and from months 9 to 15 to months 15 to 27.
conclusionsThe variability in VE algorithms indicates challenges in accurately assessing VE against asymptomatic infections. TAK-003 had a modest impact on asymptomatic dengue infections in the first months postvaccination, mainly in participants with baseline seropositivity.
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