Evidence map›Paper›PMID 25801652›Full record

Trial reportThe Journal of infectious diseases2015

Robust and Balanced Immune Responses to All 4 Dengue Virus Serotypes Following Administration of a Single Dose of a Live Attenuated Tetravalent Dengue Vaccine to Healthy, Flavivirus-Naive Adults.

Beth D Kirkpatrick, Anna P Durbin, Kristen K Pierce, Marya P Carmolli, Cecilia M Tibery, Palmtama L Grier, Noreen Hynes, Sean A Diehl, Dan Elwood, Adrienne P Jarvis and 10 more

3 registry-linked trialsOpen access · bronzeAbstract readRandomized 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 3 registered trials, which are not on this map. Cited by 117 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
117citing papers in PubMed, 1 pooled it
24.2field-weighted citation impact, top 1% of its field
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.

NCT01072786 phase1completednot on this map

A Phase 1 Evaluation of the Safety and Immunogenicity of Five Admixtures of TetraVax-DV, a Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine, in Healthy Flavivirus-naïve Adult Subjects

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2010 to 2012Enrolled141ConditionsDengueArmsTetraVax-DV Vaccine-Admixture 1, TetraVax-DV Vaccine-Admixture 2, TetraVax-DV Vaccine-Admixture 3, TetraVax-DV Vaccine-Admixture 4, Placebo
NCT01436422 phase1completednot on this map

A Phase 1 Evaluation of the Safety and Immunogenicity of the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixtures TV003 and TV005 in Healthy Flavivirus-Naïve Adult Subjects

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2011 to 2014Enrolled112ConditionsDengueArmsTetraVax-DV Vaccine - Admixture TV003, TetraVax-DV Vaccine - Admixture TV005, Placebo
NCT02678455 phase2completednot on this mapstarted 2016, after this paper: background citation

Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Immunogenicity of the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixture TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2016 to 2020Enrolled192ConditionsDengueArmsTV005 vaccine, Placebo
3 · Its place in the literature

Who cites it

117 citing papers in PubMed, 1 synthesis or guideline pooled it, 196 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
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  5. Trial
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  8. Licensed Dengue Vaccine: Public Health Conundrum and Scientific Challenge.The American journal of tropical medicine and hygiene · 2016
    Trial
  9. Trial
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Dengue Vaccines.Current topics in microbiology and immunology · 2026
    Review
  17. Review
  18. Dengue Dilemma: Navigating Cross-Reactivity and Immune Challenges.Current topics in microbiology and immunology · 2026
    Review
  19. T Cell Responses During Dengue Infection.Current topics in microbiology and immunology · 2026
    Review
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 3 institutions in 1 country.

Beth D KirkpatrickDepartment of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.
Anna P DurbinCenter for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.
Kristen K PierceDepartment of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.
Marya P CarmolliDepartment of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.
Cecilia M TiberyCenter for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.
Palmtama L GrierCenter for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.
Noreen HynesCenter for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.
Sean A DiehlDepartment of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.
Dan ElwoodCenter for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.
Adrienne P JarvisDepartment of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.
Beulah P SabundayoCenter for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.
Caroline E LyonDepartment of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.
Catherine J LarssonDepartment of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.
Matthew JoCenter for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.
Janece M LovchikCenter for Immunization Research, Johns Hopkins University School of Public Health, Baltimore.
Catherine J LukeNational Institutes of Allergy and Infectious Diseases, Bethesda, Maryland.
Mary C WalshDepartment of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.
Ellen A FraserDepartment of Medicine, Vaccine Testing Center, University of Vermont College of Medicine, Burlington.
Kanta SubbaraoNational Institutes of Allergy and Infectious Diseases, Bethesda, Maryland.
Steven S WhiteheadNational Institutes of Allergy and Infectious Diseases, Bethesda, Maryland.
University of Vermont · USJohns Hopkins University · USNational Institute of Allergy and Infectious Diseases · US

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
NIAID NIH HHS HHSN272200900010C
6 · The paper itself

Abstract

backgroundThe 4 serotypes of dengue virus, DENV-1-4, are the leading cause of arboviral disease globally. The ideal dengue vaccine would provide protection against all serotypes after a single dose.

methodsTwo randomized, placebo-controlled trials were performed with 168 flavivirus-naive adults to demonstrate the safety and immunogenicity of a live attenuated tetravalent dengue vaccine (TV003), compared with those of a second tetravalent vaccine with an enhanced DENV-2 component (TV005), and to evaluate the benefit of a booster dose at 6 months. Safety data, viremia, and neutralizing antibody titers were evaluated.

resultsA single dose of TV005 elicited a tetravalent response in 90% of vaccinees by 3 months after vaccination and a trivalent response in 98%. Compared with TV003, the higher-dose DENV-2 component increased the observed frequency of immunogenicity to DENV-2 in the TV005 trial. Both the first and second doses were well tolerated. Neither vaccine viremia, rash, nor a significant antibody boost were observed following a second dose.

conclusionsA single subcutaneous dose of TV005 dengue vaccine is safe and induces a tetravalent antibody response at an unprecedented frequency among vaccinees. A second dose has limited benefit and appears to be unnecessary. Studies to confirm these findings and assess vaccine efficacy will now move to populations in regions where DENV transmission is endemic. CLINICAL TRIALS REGISTRATION: NCT01072786 and NCT01436422.

Indexed as

AdolescentAdultAntibodies, NeutralizingAntibodies, ViralDengue VaccinesDengue VirusDrug-Related Side Effects and Adverse ReactionsFemaleHealthy VolunteersHumansInjections, SubcutaneousMaleMiddle AgedPlacebosVaccinationVaccines, AttenuatedAntibodies, NeutralizingAntibodies, ViralDengue VaccinesPlacebosVaccines, Attenuatedclinical trialdengue vaccinelive attenuated tetravalent vaccine

Identifiers

PMID25801652
PMCPMC4612392
OpenAlexW2151777556

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.