Evidence map›Paper›PMID 25791116›Full record

Trial reportThe Journal of infectious diseases2015

Safety and Immunogenicity of a Live Attenuated Tetravalent Dengue Vaccine Candidate in Flavivirus-Naive Adults: A Randomized, Double-Blinded Phase 1 Clinical Trial.

Sarah L George, Mimi A Wong, Tina J T Dube, Karen L Boroughs, Janae L Stovall, Betty E Luy, Aurelia A Haller, Jorge E Osorio, Linda M Eggemeyer, Sharon Irby-Moore and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01110551 (A Double-Blind Randomized, Placebo-Controlled, Phase I Dose Escalation Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers), which is not on this map. Cited by 50 papers.

0numbers the graph read from it
0cells of the map it votes in
50citing 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.

NCT01110551 phase1completednot on this map

A Double-Blind Randomized, Placebo-Controlled, Phase I Dose Escalation Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2010 to 2012Enrolled72ConditionsDengueArmsPlacebo (SC), Placebo (ID), Modified Live Tetravalent Chimeric Dengue Vaccine (SC), Modified Live Tetravalent Chimeric Dengue Vaccine (ID)
3 · Its place in the literature

Who cites it

50 citing papers in PubMed.

  1. Trial
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  4. Clinical Safety Experience of TAK-003 for Dengue Fever: A New Tetravalent Live Attenuated Vaccine Candidate.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Trial
  5. Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  19. Review
  20. 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

13 authors.

Sarah L GeorgeDepartment of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine St. Louis Veterans Administration Medical Center, Missouri.
Mimi A WongEMMES Corporation, Rockville, Maryland.
Tina J T DubeEMMES Corporation, Rockville, Maryland.
Karen L BoroughsArboviral Diseases Branch, Division of Vector-Borne Disease, Centers for Disease Control and Prevention, Fort Collins, Colorado.
Janae L StovallArboviral Diseases Branch, Division of Vector-Borne Disease, Centers for Disease Control and Prevention, Fort Collins, Colorado.
Betty E LuyArboviral Diseases Branch, Division of Vector-Borne Disease, Centers for Disease Control and Prevention, Fort Collins, Colorado.
Aurelia A HallerArboviral Diseases Branch, Division of Vector-Borne Disease, Centers for Disease Control and Prevention, Fort Collins, Colorado.
Jorge E OsorioTakeda Vaccines, Deerfield, Illinois.
Linda M EggemeyerDepartment of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine.
Sharon Irby-MooreDepartment of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine.
Sharon E FreyDepartment of Internal Medicine, Division of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine.
Claire Y-H HuangArboviral Diseases Branch, Division of Vector-Borne Disease, Centers for Disease Control and Prevention, Fort Collins, Colorado.
Dan T StinchcombTakeda Vaccines, Deerfield, Illinois.

Funding

EVALUATION OF CONTROL MEASURES AGAINST DISEASES OTHER THAN AIDS-266025464N01AI025464 · NIAID · SAINT LOUIS UNIVERSITY · PI CHAPLESKI, ELIZABETH · 2003 to 2006
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NIAID NIH HHS N01 AI025464NIAID NIH HHS N01-AI25464
6 · The paper itself

Abstract

backgroundDengue viruses (DENVs) infect >300 million people annually, causing 96 million cases of dengue disease and 22 000 deaths [1]. A safe vaccine that protects against DENV disease is a global health priority [2].

methodsWe enrolled 72 flavivirus-naive healthy adults in a phase 1 double-blinded, randomized, placebo-controlled dose-escalation trial (low and high dose) of a live attenuated recombinant tetravalent dengue vaccine candidate (TDV) given in 2 doses 90 days apart. Volunteers were followed for safety, vaccine component viremia, and development of neutralizing antibodies to the 4 DENV serotypes.

resultsThe majority of adverse events were mild, with no vaccine-related serious adverse events. Vaccinees reported injection site pain (52% vs 17%) and erythema (73% vs 25%) more frequently than placebo recipients. Low levels of TDV-serotype 2 (TDV-2), TDV-3, and TDV-4 viremia were observed after the first but not second administration of vaccine. Overall seroconversion rates and geometric mean neutralization titers after 2 doses were 84.2% and 54.1, respectively, for DENV serotype 1 (DENV-1); 92.1% and 292.8, respectively, for DENV-2; 86.8% and 32.3, respectively, for DENV-3; and 71.1% and 15.0, respectively, for DENV-4. More than 90.0% of high-dose recipients had trivalent or broader responses.

conclusionsTDV was generally well tolerated, induced trivalent or broader neutralizing antibodies to DENV in most flavivirus-naive vaccinees, and is undergoing further development. CLINICAL TRIALS REGISTRATION: NCT01110551.

Indexed as

VaccinationAdolescentAdultAntibodies, NeutralizingDengueDengue VaccinesDengue VirusDouble-Blind MethodFemaleHumansMaleMiddle AgedSafetyVaccines, AttenuatedViremiaYoung AdultAntibodies, NeutralizingDengue VaccinesVaccines, Attenuatedclinical trialDengue vaccinelive attenuated tetravalentneutralizing antibodyviremia

Identifiers

PMID25791116
PMCPMC4559193

What OpenQuestion holds

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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.