Trial reportThe Journal of infectious diseases2023
Antibodies Produced in Response to a Live-Attenuated Dengue Vaccine Are Functional in Activating the Complement System.
Trial report in The Journal of infectious diseases, 2023. 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 8 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 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
8 citing papers in PubMed, 8 citations in OpenAlex.
- IgG, IgM, and Nonstructural Protein 1 Response Profiles after Receipt of Tetravalent Dengue Vaccine TAK-003 in a Phase 2 Randomized Controlled Trial.The American journal of tropical medicine and hygiene · 2024Trial
- Functional antibody responses and protection against symptomatic dengue.Communications medicine · 2026Review
- The TAK-003 story: key decisions that shaped development of a tetravalent dengue vaccine.NPJ vaccines · 2026Review
- Mapping immune responses to TAK-003 dengue vaccine: immunogenicity across the clinical development program.Frontiers in immunology · 2026Review
- Anti-Dengue Virus Antibody Avidity Correlates With Protection Against Symptomatic Dengue Virus Infection.The Journal of infectious diseases · 2025Article
- Applications and insights from continuous dengue virus infection in a stable cell line.Frontiers in immunology · 2025Article
- An effective pan-serotype dengue vaccine and enhanced control strategies could help in reducing the severe dengue burden in Bangladesh-A perspective.Frontiers in microbiology · 2024Review
- Bridging the immunogenicity of a tetravalent dengue vaccine (TAK-003) from children and adolescents to adults.NPJ vaccines · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAntibody-driven complement system (CS) activation has been associated with protection against symptomatic dengue virus (DENV) infection. Aggregation, opsonization, lysis, and phagocytosis are mechanisms triggered by antibody-antigen immunocomplexes following fixation of the component 1q (C1q) and activation of the classical pathway. As a result, DENV neutralization and clearance are facilitated, whereas antibody-dependent enhancement of infection is inhibited. We investigated the ability of antibodies produced in response to Takeda's dengue vaccine candidate, TAK-003, to fix C1q and activate CS.
methodsSerum samples were collected from seronegative and seropositive participants in a phase 2 clinical trial (DEN-203), pre- and postvaccination. Samples were evaluated for the presence of complement-fixing antibodies (CFAs) against DENV using a Luminex multiplex-based immunoassay.
resultsTAK-003 elicited production of CFAs against all 4 DENV serotypes, which persisted for 1 year postvaccination, irrespective of baseline serostatus. CFA levels were correlated with neutralizing antibody titers and virus-binding total IgG and IgG1 concentrations. Furthermore, efficiency of CFA fixation was greater in samples with higher polyclonal IgG avidity.
conclusionsThese results indicate that antibodies produced after TAK-003 vaccination are functional in both activating CS and neutralizing virus infection by all DENV serotypes, which may contribute to efficacy of TAK-003. 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.