Trial reportThe American journal of tropical medicine and hygiene2015
A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico.
Trial report in The American journal of tropical medicine and hygiene, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00468858 (Phase II, Randomized, Double-blind, Placebo-controlled Study of Two Doses of WRAIR Live Attenuated Tetravalent Dengue Vaccine Formulations, Administered Six Months Apart, to Healthy Adults and Children), which is not on this map. Cited by 22 papers.
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.
Phase II, Randomized, Double-blind, Placebo-controlled Study of Two Doses of WRAIR Live Attenuated Tetravalent Dengue Vaccine Formulations, Administered Six Months Apart, to Healthy Adults and Children
Who cites it
22 citing papers in PubMed.
- Cell-mediated immune responses to different formulations of a live-attenuated tetravalent dengue vaccine candidate in subjects living in dengue endemic and non-endemic regions.Human vaccines & immunotherapeutics · 2019Trial
- Phase I Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico.The American journal of tropical medicine and hygiene · 2018Trial
- In a randomized trial, the live attenuated tetravalent dengue vaccine TV003 is well-tolerated and highly immunogenic in subjects with flavivirus exposure prior to vaccination.PLoS neglected tropical diseases · 2017Trial
- Update on efficacy, safety, and immunogenicity of Dengue vaccines: a systematic review and meta-analysis.Le infezioni in medicina · 2026Review
- Opportunities and challenges of mRNA technologies in development of dengue virus vaccine.Frontiers in immunology · 2025Review
- Dengue fever in hyperglycemic patients: an emerging public health concern demanding eyes on the effective management strategies.Health science reports · 2024Article
- Article
- Approaches of dengue control: vaccine strategies and future aspects.Frontiers in immunology · 2024Review
- Challenges on the development of a dengue vaccine: a comprehensive review of the state of the art.The Journal of general virology · 2023Review
- Dengue: Update on Clinically Relevant Therapeutic Strategies and Vaccines.Current treatment options in infectious diseases · 2023Review
- Review
- Controlled Human Infection Models To Accelerate Vaccine Development.Clinical microbiology reviews · 2022Review
- Updates on Dengue Vaccine and Antiviral: Where Are We Heading?Molecules (Basel, Switzerland) · 2021Review
- Anti-dengue Vaccines: From Development to Clinical Trials.Frontiers in immunology · 2020Review
- Challenges in Dengue Vaccines Development: Pre-existing Infections and Cross-Reactivity.Frontiers in immunology · 2020Review
- Review
- Recent Developments in Recombinant Protein-Based Dengue Vaccines.Frontiers in immunology · 2018Review
- The US Military Commitment to Vaccine Development: A Century of Successes and Challenges.Frontiers in immunology · 2018Review
- Article
- N-Desmethylclozapine, Fluoxetine, and Salmeterol Inhibit Postentry Stages of the Dengue Virus Life Cycle.Antimicrobial agents and chemotherapy · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This was a double-blind, randomized, controlled, phase II clinical trial, two dose study of re-derived, live-attenuated, tetravalent dengue virus (TDEN) vaccine (two formulations) or placebo in subjects 1-50 years of age. Among the 636 subjects enrolled, 331 (52%) were primed, that is, baseline seropositive to at least one dengue virus (DENV) type. Baseline seropositivity prevalence increased with age (10% [< 2 years], 26% [2-4 years], 60% [5-20 years], and 93% [21-50 years]). Safety profiles of TDEN vaccines were similar to placebo regardless of priming status. No vaccine-related serious adverse events (SAEs) were reported. Among unprimed subjects, immunogenicity (geometric mean antibody titers [GMT] and seropositivity rates) for each DENV increased substantially in both TDEN vaccine groups with at least 74.6% seropositive for four DENV types. The TDEN vaccine candidate showed an acceptable safety and immunogenicity profile in children and adults ranging from 1 to 50 years of age, regardless of priming status. ClinicalTrials.gov: NCT00468858.
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.