ArticleHuman vaccines & immunotherapeutics2018
Safety issues from a Phase 3 clinical trial of a live-attenuated chimeric yellow fever tetravalent dengue vaccine.
Article in Human vaccines & immunotherapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed, 79 citations in OpenAlex.
- A phase I randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a live-attenuated quadrivalent dengue vaccine in flavivirus-naïve and flavivirus-experienced healthy adults.Human vaccines & immunotherapeutics · 2022Trial
- Innate Lymphoid Cells Activation and Transcriptomic Changes in Response to Human Dengue Infection.Frontiers in immunology · 2021Trial
- Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial.The American journal of tropical medicine and hygiene · 2020Trial
- Association of dengue virus-specific polyfunctional T-cell responses with clinical disease severity in acute dengue infection.Immunity, inflammation and disease · 2019Trial
- Dengue vaccines: The role of a correlate of protection in evaluating vaccine safety and risk.Vaccine · 2026Article
- Harnessing Nanocarriers to Advance Vaccine Development.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- A novel immunocompetent transgenic mouse model of DHF reveals Syk-mediated Th2-polarized cytokine storm as a key driver of vascular leakage.Emerging microbes & infections · 2025Article
- Dengue encephalitis: what's new?Current opinion in infectious diseases · 2025Review
- Spatiotemporal distribution of sustained dengue hotspots associated with climate and urbanisation in Singapore.Scientific reports · 2025Article
- Discovery of Potent Degraders of the Dengue Virus Envelope Protein.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Article
- The Urgent Need for Dengue Vaccination: Combating an Escalating Public Health Crisis in Pakistan.Vaccines · 2024Article
- A pre-vaccination immune metabolic interplay determines the protective antibody response to a dengue virus vaccine.Cell reports · 2024Article
- The (unresolved) antibody paradox.The Journal of clinical investigation · 2024Article
- Discovery of Potent Degraders of the Dengue Virus Envelope Protein.bioRxiv : the preprint server for biology · 2024Article
- Effective inhibition of dengue virus replication using 3'UTR-targeted Vivo-Morpholinos.Frontiers in immunology · 2024Article
- DENV-2 NS1 promotes AMPK-LKB1 interaction to activate AMPK/ERK/mTOR signaling pathway to induce autophagy.Virology journal · 2023Article
- Safety of Dengue Vaccine?Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Immunization with different recombinant West Nile virus envelope proteins induces varying levels of serological cross-reactivity and protection from infection.Frontiers in cellular and infection microbiology · 2023Article
- Immunogenicity of a Live Dengue Vaccine (TAK-003).The Journal of infectious diseases · 2022Article
- Antibody-Dependent Enhancement (ADE) and the role of complement system in disease pathogenesis.Molecular immunology · 2022Review
Corrections and comments
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Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A tetravalent live-attenuated 3-dose vaccine composed of chimeras of yellow fever 17D and the four dengue viruses (CYD, also called Dengvaxia) completed phase 3 clinical testing in over 35,000 children leading to a recommendation that vaccine be administered to >/ = 9 year-olds residing in highly dengue- endemic countries. When clinical trial results were assessed 2 years after the first dose, vaccine efficacy among seropositives was high, but among seronegatives efficacy was marginal. Breakthrough dengue hospitalizations of vaccinated children occurred continuously over a period of 4-5 years post 3rd dose in an age distribution suggesting these children had been vaccinated when seronegative. This surmise was validated recently when the manufacturer reported that dengue NS1 IgG antibodies were absent in sera from hospitalized vaccinated children, an observation consistent with their having received Dengvaxia when seronegative. Based upon published efficacy data and in compliance with initial published recommendations by the manufacturer and WHO the Philippine government undertook to vaccinate 800,000-plus 9 year-olds starting in April 2016. Eighteen months later, dengue hospitalizations and a deaths were reported among vaccinated children. The benefits of administering Dengvaxia predicted by the manufacturer, WHO and others derive from scoring dengue hospitalizations of vaccinated children as vaccine failures rather than as vaccine enhanced dengue disease. Recommended regimens for administration of Dengvaxia should have been structured to warn of and avoid serious adverse events.
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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.