Trial reportHuman vaccines & immunotherapeutics2023
An open-label, Phase 3 trial of TAK-003, a live attenuated dengue tetravalent vaccine, in healthy US adults: immunogenicity and safety when administered during the second half of a 24-month shelf-life.
Trial report in Human vaccines & immunotherapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03771963 (An Open-Label, Phase 3 Trial to Investigate the Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
An Open-Label, Phase 3 Trial to Investigate the Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) at the End of Shelf Life in Healthy Adults in Non-Endemic Country(Ies) for Dengue
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Worldwide distribution, symptoms and diagnosis of the coinfections between malaria and arboviral diseases: a systematic review.Memorias do Instituto Oswaldo Cruz · 2024Pooled 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
- Baseline Anti-Dengue IgG Seroprevalence in a Pediatric Brazilian Population Before TAK-003 Vaccination.The American journal of tropical medicine and hygiene · 2026Article
- Research progress of dengue virus T cell epitope mediated cellular immunity in avoiding ADE.Frontiers in immunology · 2026Review
- Mapping immune responses to TAK-003 dengue vaccine: immunogenicity across the clinical development program.Frontiers in immunology · 2026Review
- Co-circulation of Plasmodium vivax and Arboviruses in the Brazil-French Guiana Border.Revista da Sociedade Brasileira de Medicina Tropical · 2026Article
- T Cell Responses During Dengue Infection.Current topics in microbiology and immunology · 2026Review
- Dengue-SARS-CoV-2 interactions: immune crosstalk, variant emergence, and clinical outcomes.Frontiers in immunology · 2026Review
- Design of Hyperglycosylated Zika Virus E Proteins that Focus Antibody Recognition on the Complex E Dimer Epitope.ACS chemical biology · 2025Article
- State of the Art on Vaccine Development Against Dengue Infection: Scoping Review of the Literature.Infectious disease reports · 2025Review
- A two-component cocktail of engineered DIII nanoparticles elicits broadly neutralizing antibody responses against dengue virus in mice.iScience · 2025Article
- Multivalent administration of dengue E dimers on liposomes elicits type-specific neutralizing responses without immune interference.NPJ vaccines · 2025Article
- Review
- Review
- Advancements in dengue vaccines: A historical overview and pro-spects for following next-generation candidates.Journal of microbiology (Seoul, Korea) · 2025Review
- Review
- Opportunities and challenges of mRNA technologies in development of dengue virus vaccine.Frontiers in immunology · 2025Review
- Atypical dengue fever in a partially vaccinated patient: a case report.Revista do Instituto de Medicina Tropical de Sao Paulo · 2025Article
- Exploring Dengue Infection in a Vaccinated Individual: Preliminary Molecular Diagnosis and Sequencing Insights.Viruses · 2024Article
- A chimeric RNA consisting of siRNA and aptamer for inhibiting dengue virus replication.NAR molecular medicine · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Dengue is caused by a mosquito-transmitted flavivirus. The disease is now endemic to many tropical and subtropical regions, manifesting as approximately 96 million symptomatic cases of dengue each year. Clinical trials have shown TAK-003 (Qdenga®), a live attenuated dengue tetravalent vaccine, to be well-tolerated, immunogenic, and efficacious in adults with no prior exposure to dengue virus infection living in non-endemic regions, as well as in adults and children living in dengue-endemic areas. This open-label, single-arm phase 3 trial (NCT03771963) was conducted in two dengue non-endemic areas of the USA, and it evaluated the immunogenicity and safety of naturally-aged TAK-003 administered to adult participants. Overall, the immunogenicity data from this trial are consistent with those reported from other TAK-003 phase 2 and 3 trials, and the safety data are consistent with the broader integrated safety data analysis. The data show that naturally-aged TAK-003 had a well-tolerated reactogenicity and adverse events profile when administered in the second half of its clinical 24-month shelf-life and that it still elicited an immune response that persisted up to 6 months after the second dose against all four dengue serotypes, with no important safety risks identified during the trial.
Indexed as
Identifiers
What OpenQuestion holds
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.