Evidence map›Paper›PMID 23735680›Full record

Trial reportVaccine2013

Vaccination of volunteers with low-dose, live-attenuated, dengue viruses leads to serotype-specific immunologic and virologic profiles.

Janet C Lindow, Anna P Durbin, Stephen S Whitehead, Kristen K Pierce, Marya P Carmolli, Beth D Kirkpatrick

Abstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Dengue Vaccines: An Update.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022
    Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Human CD4Journal of virology · 2017
    Article
  17. Article
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Janet C LindowUniversity of Vermont College of Medicine, Vaccine Testing Center and Unit of Infectious Diseases, 95 Carrigan Drive, Stafford Hall 110, Burlington, VT, USA.
Anna P Durbin
Stephen S Whitehead
Kristen K Pierce
Marya P Carmolli
Beth D Kirkpatrick

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
Vermont Immunobioloigy/ Infectious Diseases CenterP20GM103496 · NIGMS · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI BUDD, RALPH C · 2012 to 2015
$8.7M
Intramural NIH HHSNIAID NIH HHS HHSN272200900010CNIAID NIH HHS N01 AI015444NIGMS NIH HHS P20 GM103496
6 · The paper itself

Abstract

There are currently no vaccines or therapeutics to prevent dengue disease which ranges in severity from asymptomatic infections to life-threatening illness. The National Institute of Allergy and Infectious Diseases (NIAID) Division of Intramural Research has developed live, attenuated vaccines to each of the four dengue serotypes (DENV-1-DENV-4). Two doses (10PFU and 1000PFU) of three monovalent vaccines were tested in human clinical trials to compare safety and immunogenicity profiles. DEN4Δ30 had been tested previously at multiple doses. The three dengue vaccine candidates tested (DEN1Δ30, DEN2/4Δ30, and DEN3Δ30/31) were very infectious, each with a human infectious dose 50%≤ 10PFU. Further, infectivity rates ranged from 90 to 100% regardless of dose, excepting DEN2/4Δ30 which dropped from 100% at the 1000PFU dose to 60% at the 10PFU dose. Mean geometric peak antibody titers did not differ significantly between doses for DEN1Δ30 (92 ± 19 vs. 214 ± 97, p=0.08); however, significant differences were observed between the 10PFU and 1000PFU doses for DEN2/4Δ30, 19 ± 9 vs. 102 ± 25 (p=0.001), and DEN3Δ30/31, 119 ± 135 vs. 50 ± 50 (p=0.046). No differences in the incidences of rash, neutropenia, or viremia were observed between doses for any vaccines, though the mean peak titer of viremia for DEN1Δ30 was higher at the 1000PFU dose (0.5 ± 0 vs. 1.1 ± 0.1, p=0.007). These data demonstrate that a target dose of 1000PFU for inclusion of each dengue serotype into a tetravalent vaccine is likely to be safe and generate a balanced immune response for all serotypes.

Indexed as

AdultAntibodies, NeutralizingAntibodies, ViralDengueDengue VaccinesDengue VirusDose-Response Relationship, ImmunologicDouble-Blind MethodFemaleHumansMaleNeutralization TestsSerotypingVaccines, AttenuatedViral LoadViremiaAntibodies, NeutralizingAntibodies, ViralDengue VaccinesVaccines, AttenuatedDengue vaccineDengue virusHID(50)Low doseNeutralizing antibodiesViremia

Identifiers

PMID23735680
PMCPMC3777849

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.