Trial reportHuman vaccines & immunotherapeutics2020
Immunogenicity and safety of lyophilized and liquid dengue tetravalent vaccine candidate formulations in healthy adults: a randomized, phase 2 clinical trial.
Trial report in Human vaccines & immunotherapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02193087 (A Randomized, Double Blind, Phase 2 Study to Assess the Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate), which is not on this map. Cited by 22 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.
A Randomized, Double Blind, Phase 2 Study to Assess the Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Adults
Who cites it
22 citing papers in PubMed.
- 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
- Immunogenicity and safety of concomitant and sequential administration of yellow fever YF-17D vaccine and tetravalent dengue vaccine candidate TAK-003: A phase 3 randomized, controlled study.PLoS neglected tropical diseases · 2023Trial
- Clinical Safety Experience of TAK-003 for Dengue Fever: A New Tetravalent Live Attenuated Vaccine Candidate.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Trial
- Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination.The Journal of infectious diseases · 2022Trial
- Update on efficacy, safety, and immunogenicity of Dengue vaccines: a systematic review and meta-analysis.Le infezioni in medicina · 2026Review
- Mapping immune responses to TAK-003 dengue vaccine: immunogenicity across the clinical development program.Frontiers in immunology · 2026Review
- Overcoming dengue vaccine challenges through next-generation virus-like particle immunization strategies.Frontiers in cellular and infection microbiology · 2025Review
- Review
- Review
- The Effect of Age on Dengue Presentation and the Diagnostic Accuracy of the 2015 Pan American Health Organization Case Criteria in a Puerto Rican Cohort.Open forum infectious diseases · 2023Article
- Review
- Article
- Vaccine development for mosquito-borne viral diseases.Frontiers in immunology · 2023Review
- Review
- Review
- Controlled Human Infection Models To Accelerate Vaccine Development.Clinical microbiology reviews · 2022Review
- Dengue Vaccines: An Update.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Review
- Recent Insights Into the Molecular Mechanism of Toll-Like Receptor Response to Dengue Virus Infection.Frontiers in microbiology · 2021Review
- Immunogenicity and safety of a tetravalent dengue vaccine in dengue-naïve adolescents in Mexico City.Revista panamericana de salud publica = Pan American journal of public health · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Takeda has developed a live-attenuated dengue tetravalent vaccine candidate (TAK-003) which has been shown to be immunogenic with acceptable reactogenicity in phase 1 trials. In agreement with World Health Organization prequalification requirements for dengue vaccines, Takeda has manufactured a lyophilized formulation of TAK-003 that allows stable storage at +2°C to +8°C. This randomized, double-blind, phase 2 study (NCT02193087) was performed in 1002 healthy dengue-naïve adults, 18-49 years of age, across seven centers in the USA to compare the safety and immunogenicity of one or two doses of a lyophilized TAK-003 formulation with the liquid TAK-003 formulation used in previous phase 1 studies. The primary objective was to show immunologic equivalence in terms of geometric mean titers (GMT) of neutralizing antibodies to the four dengue serotypes one month after one dose of the lyophilized and liquid formulations. Secondary assessments were of safety and seropositivity rates, including after a second dose. The primary endpoint was not met, because immunologic equivalence after one dose was only shown for the DENV-2 serotype. Nonetheless, GMTs and seropositivity rates to all four serotypes were achieved with all formulations after two doses and are in line with what was observed in previous studies. Additionally, in view of the acceptable reactogenicity, with no vaccine-related serious adverse events reported, these data support continuing further clinical development of the lyophilized TAK-003 formulation.
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