Evidence map›Paper›PMID 24865677›Full record

Trial reportThe American journal of tropical medicine and hygiene2014

Safety and immunogenicity of a rederived, live-attenuated dengue virus vaccine in healthy adults living in Thailand: a randomized trial.

Veerachai Watanaveeradej, Robert V Gibbons, Sriluck Simasathien, Ananda Nisalak, Richard G Jarman, Angkool Kerdpanich, Elodie Tournay, Rafael De La Barrerra, Francis Dessy, Jean-François Toussaint and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00370682 (Phase II, Randomized, Double-blind, Single Center, Controlled Study of Two Doses of Different Formulations of the WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to a Placebo Control, Administered on a 0-6 Month Schedule, to Healthy Adults), which is not on this 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.

NCT00370682 phase2completednot on this map

Phase II, Randomized, Double-blind, Single Center, Controlled Study of Two Doses of Different Formulations of the WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to a Placebo Control, Administered on a 0-6 Month Schedule, to Healthy Adults

TypeinterventionalSponsorU.S. Army Medical Research and Development CommandRan2007 to 2008Enrolled120ConditionsDengueArmsT-DEN F17, T-DEN F-19, Placebo Comparator
3 · Its place in the literature

Who cites it

21 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Dengue Vaccines.Current topics in microbiology and immunology · 2026
    Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Frontiers in cellular and infection microbiology · 2019
    Review
  15. Article
  16. Review
  17. Article
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  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.

Veerachai WatanaveeradejDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Robert V GibbonsDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Sriluck SimasathienDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Ananda NisalakDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Richard G JarmanDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Angkool KerdpanichDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Elodie TournayDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Rafael De La BarrerraDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Francis DessyDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Jean-François ToussaintDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Kenneth H EckelsDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
Stephen J ThomasDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania stephen.j.thomas3.mil@mail.mil.
Bruce L InnisDepartment of Pediatrics, Phramongkutklao Hospital (PMK), Bangkok, Thailand; US Army Medical Component-Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, Wavre, Belgium; Bioproduction Facility, Translational Medicine Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Safety and immunogenicity of two formulations of a live-attenuated tetravalent dengue virus (TDEN) vaccine produced using rederived master seeds from a precursor vaccine were tested against a placebo control in a phase II, randomized, double blind trial (NCT00370682). Two doses were administered 6 months apart to 120 healthy, predominantly flavivirus-primed adults (87.5% and 97.5% in the two vaccine groups and 92.5% in the placebo group). Symptoms and signs reported after vaccination were mild to moderate and transient. There were no vaccine-related serious adverse events or dengue cases reported. Asymptomatic, low-level viremia (dengue virus type 2 [DENV-2], DENV-3, or DENV-4) was detected in 5 of 80 vaccine recipients. One placebo recipient developed a subclinical natural DENV-1 infection. All flavivirus-unprimed subjects and at least 97.1% of flavivirus-primed subjects were seropositive to antibodies against all four DENV types 1 and 3 months post-TDEN dose 2. The TDEN vaccine was immunogenic with an acceptable safety profile in flavivirus-primed adults.

Indexed as

VaccinationAdultAntibodies, ViralDengueDengue VaccinesDengue VirusFemaleHumansImmunity, HumoralImmunization ScheduleMaleMolecular TypingPlacebosThailandVaccines, AttenuatedAntibodies, ViralDengue VaccinesPlacebosVaccines, Attenuated

Identifiers

PMID24865677
PMCPMC4080550

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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.