Evidence map›Paper›PMID 19861619›Full record

Trial reportThe American journal of tropical medicine and hygiene2009

Phase 1 trial of the dengue virus type 4 vaccine candidate rDEN4{Delta}30-4995 in healthy adult volunteers.

Peter F Wright, Anna P Durbin, Stephen S Whitehead, Mine R Ikizler, Susan Henderson, Joseph E Blaney, Bhavin Thumar, Sharon Ankrah, Michael T Rock, Brett A McKinney and 2 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–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

21 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Dengue Vaccines.Current topics in microbiology and immunology · 2026
    Review
  5. Article
  6. Frontiers in cellular and infection microbiology · 2019
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Issues related to recent dengue vaccine development.Tropical medicine and health · 2011
    Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. The necessity and quandaries of dengue vaccine development.The Journal of infectious diseases · 2011
    Article
  20. Dengue: a continuing global threat.Nature reviews. Microbiology · 2010
    Review
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

12 authors.

Peter F WrightDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA. peter.f.wright@dartmouth.edu
Anna P Durbin
Stephen S Whitehead
Mine R Ikizler
Susan Henderson
Joseph E Blaney
Bhavin Thumar
Sharon Ankrah
Michael T Rock
Brett A McKinney
Brian R Murphy
Alexander C Schmidt

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
Pathogenesis and countermeasures of poxviruses, hemorrhagic fever viruses, MERSZIAAI001025 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI JOHNSON, REED · 2009 to 2018
$14.1M
Intramural NIH HHS Z99 AI999999
6 · The paper itself

Abstract

rDEN4Delta30-4995 is a live attenuated dengue virus type 4 (DENV4) vaccine candidate specifically designed as a further attenuated derivative of the rDEN4Delta30 parent virus. In a previous study, 5 of 20 vaccinees who received 10(5) plaque-forming units (PFU) of rDEN4Delta30 developed a transient elevation of the serum alanine aminotransferase (ALT) level and an asymptomatic maculopapular rash developed in 10 of 20. In the current study, 28 healthy adult volunteers were randomized to receive 10(5) PFU of rDEN4Delta30-4995 (20) or placebo (8) as a single subcutaneous injection. The vaccine was safe, well-tolerated, and immunogenic. An asymptomatic generalized maculopapular rash and elevations in ALT levels were observed in 10% of the rDEN4Delta30-4995 vaccinees. None of the rDEN4Delta30-4995 vaccinees became viremic, yet 95% developed a four-fold or greater increase in neutralizing antibody titers. Thus, rDEN4Delta30-4995 was demonstrated to be safe, highly attenuated, and immunogenic. However, an asymptomatic localized erythematous rash at the injection site was seen in 17/20 rDEN4Delta30-4995 vaccinees. Therefore, alternative DENV4 vaccine strains were selected for further clinical development.

Indexed as

AdultAntibodies, ViralCytokinesDengueDengue VaccinesFemaleHumansMaleMiddle AgedYoung AdultAntibodies, ViralCytokinesDengue Vaccines

Identifiers

PMID19861619
PMCPMC2829759

What OpenQuestion holds

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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.