Evidence map›Paper›PMID 23329850›Full record

Trial reportThe Journal of infectious diseases2013

A single dose of any of four different live attenuated tetravalent dengue vaccines is safe and immunogenic in flavivirus-naive adults: a randomized, double-blind clinical trial.

Anna P Durbin, Beth D Kirkpatrick, Kristen K Pierce, Daniel Elwood, Catherine J Larsson, Janet C Lindow, Cecilia Tibery, Beulah P Sabundayo, Donna Shaffer, Kawsar R Talaat and 7 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 100 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT01696422 phase2unknown statusnot on this map

Phase II, Step-wise, Randomized, Double-blind, Controlled Clinical Trial for Safety and Immunogenicity Evaluation of a Lyophilized Formulation of Dengue 1,2,3,4 (Attenuated) Vaccine in Healthy Adults

TypeinterventionalSponsorButantan InstituteRan2013 to 2020Enrolled300ConditionsDengueArmsDengue 1,2,3,4 (attenuated) vaccine, TetraVax-DV Vaccine - Admixture TV003, Placebo
NCT01782300 phase1completednot on this map

A Phase 1 Evaluation of the Safety and Immunogenicity of a Booster Dose of TV003 Administered 12 Months After Initial Vaccination With TV003

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2013 to 2016Enrolled48ConditionsDengueArmsTV003 Vaccine, Placebo Vaccine
3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  19. Dengue Dilemma: Navigating Cross-Reactivity and Immune Challenges.Current topics in microbiology and immunology · 2026
    Review
  20. Dengue Vaccines.Current topics in microbiology and immunology · 2026
    Review

40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Anna P DurbinDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, 624 N Broadway, Rm 217, Baltimore, MD 21205, USA. adurbin@jhsph.edu
Beth D Kirkpatrick
Kristen K Pierce
Daniel Elwood
Catherine J Larsson
Janet C Lindow
Cecilia Tibery
Beulah P Sabundayo
Donna Shaffer
Kawsar R Talaat
Noreen A Hynes
Kimberli Wanionek
Marya P Carmolli
Catherine J Luke
Brian R Murphy
Kanta Subbarao
Stephen S Whitehead

Funding

Clinical Trials of Biodefense Vaccines (Dengue, West Nile Virus, TBEV)ZIAAI000987 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI WHITEHEAD, STEPHEN · 2009 to 2025
$37.9M
Intramural NIH HHSNIAID NIH HHS HHSN272200900010C
6 · The paper itself

Abstract

backgroundDengue virus (DENV) causes hundreds of millions of infections annually. Four dengue serotypes exist, and previous infection with one serotype increases the likelihood of severe disease with a second, heterotypic DENV infection.

methodsIn a randomized, placebo-controlled study, the safety and immunogenicity of 4 different admixtures of a live attenuated tetravalent (LATV) dengue vaccine were evaluated in 113 flavivirus-naive adults. Serum neutralizing antibody levels to all 4 dengue viruses were measured on days 0, 28, 42, and 180.

resultsA single dose of each LATV admixture induced a trivalent or better neutralizing antibody response in 75%-90% of vaccinees. There was no significant difference in the incidence of adverse events between vaccinees and placebo-recipients other than rash. A trivalent or better response correlated with rash and with non-black race (P < .0001). Black race was significantly associated with a reduced incidence of vaccine viremia.

conclusionsTV003 induced a trivalent or greater antibody response in 90% of flavivirus-naive vaccinees and is a promising candidate for the prevention of dengue. Race was identified as a factor influencing the infectivity of the LATV viruses, reflecting observations of the effect of race on disease severity in natural dengue infection.

Indexed as

AdultAmerican Indian or Alaska NativeAntibodies, ViralBlack PeopleDengueDengue VaccinesDengue VirusDouble-Blind MethodExanthemaFemaleHumansMaleNative Hawaiian or Pacific IslanderVaccines, AttenuatedViremiaWhite PeopleAntibodies, ViralDengue VaccinesVaccines, Attenuated

Identifiers

PMID23329850
PMCPMC3571448

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.