Trial reportThe Journal of infectious diseases2022
Long-term Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Children and Adults: A Randomized, Placebo-Controlled, Phase 2 Study.
Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01511250 (A Double-Blind, Randomized, Placebo-Controlled, Age Descending and Expansion Phase 2 Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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.
A Double-Blind, Randomized, Placebo-Controlled, Age Descending and Expansion Phase 2 Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Dengue vaccine effectiveness and safety: a systematic analysis of recent clinical trial data.Virology journal · 2025Pooled it
- Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- Serotype skewing and immune imprinting shape response to the tetravalent dengue virus Qdenga vaccine.medRxiv : the preprint server for health sciences · 2026Article
- Update on efficacy, safety, and immunogenicity of Dengue vaccines: a systematic review and meta-analysis.Le infezioni in medicina · 2026Review
- Post-marketing safety profile of dengue vaccines CYD-TDV and TAK-003: analysis of adverse event reports from a European database.Frontiers in pharmacology · 2026Article
- Mapping immune responses to TAK-003 dengue vaccine: immunogenicity across the clinical development program.Frontiers in immunology · 2026Review
- Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Review
- State of the Art on Vaccine Development Against Dengue Infection: Scoping Review of the Literature.Infectious disease reports · 2025Review
- Overcoming dengue vaccine challenges through next-generation virus-like particle immunization strategies.Frontiers in cellular and infection microbiology · 2025Review
- Review
- Dengue Fever Epidemics and the Prospect of Vaccines: A Systematic Review and Meta-Analysis Using Clinical Trials in Children.Diseases (Basel, Switzerland) · 2024Review
- Development and Characterization of a Multiplex Assay to Quantify Complement-Fixing Antibodies against Dengue Virus.International journal of molecular sciences · 2021Article
- Dengue vaccine development by the year 2020: challenges and prospects.Current opinion in virology · 2020Review
- TAK-003 Dengue Vaccine Safety: Evidence from a Systematic Review and Meta-analysis of Clinical Trials.Indian journal of community medicine : official publication of Indian Association of Preventive & Social MedicineReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe report long-term safety and immunogenicity of Takeda's tetravalent dengue vaccine candidate (TAK-003) in healthy children and adults living in dengue-endemic areas in Puerto Rico, Columbia, Singapore, and Thailand.
methodsIn part 1 of this phase 2, randomized, placebo-controlled trial we sequentially enrolled 1.5-45 year olds (n = 148) into 4 age-descending groups, randomized 2:1 to receive 2 doses of TAK-003 or placebo 90 days apart. In part 2, 1-11 year olds (n = 212) were enrolled and randomized 3:1 to TAK-003 or placebo groups. We assessed neutralizing antibody titers for the 4 dengue serotypes (DENV) up to month 36 in part 1, and symptomatic dengue and serious adverse events (SAEs) up to month 36 in both parts.
resultsAt month 36, seropositivity rates were 97.3%, 98.7%, 88.0% and 56.0% for DENV-1, -2, -3 and -4, respectively. Seropositivity rates varied significantly for DENV-4 according to serostatus at baseline (89.5% in seropositives versus 21.6% in seronegatives). No vaccine-related SAEs were reported.
conclusionsThe trial demonstrated persistence of neutralizing antibody titers against TAK-003 over 3 years in children and adults living in dengue-endemic countries, with limited contribution from natural infection. TAK-003 was well tolerated. CLINICAL TRIALS REGISTRATION: NCT01511250.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.