Evidence map›Paper›PMID 21148499›Full record

Trial reportThe Journal of infectious diseases2011

Phase II, randomized, double-blind, placebo-controlled, multicenter study to investigate the immunogenicity and safety of a West Nile virus vaccine in healthy adults.

Rex Biedenbender, Joan Bevilacqua, Anne M Gregg, Mike Watson, Gustavo Dayan

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00442169 (Randomized, Double-blind, Placebo Controlled Phase II Trial of the Safety, Tolerability and Immunogenicity of Lyophilized ChimeriVax-WN02 West Nile Vaccine in Healthy Adults), which is not on this map. Cited by 45 papers.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed
6.4field-weighted citation impact, top 4% 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.

NCT00442169 phase2completednot on this map

Randomized, Double-blind, Placebo Controlled Phase II Trial of the Safety, Tolerability and Immunogenicity of Lyophilized ChimeriVax-WN02 West Nile Vaccine in Healthy Adults

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2005 to 2009Enrolled208ConditionsWest Nile FeverArmsChimeriVax-WN02 Low Dose, ChimeriVax-WN02 Medium Dose, ChimeriVax-WN02 High Dose, 0.9% Saline solution, 0.9 % NaCl solution
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 92 citations in OpenAlex.

  1. Trial
  2. Review
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  4. Article
  5. Article
  6. Review
  7. Review
  8. Self-Replicating RNA Derived from the Genomes of Positive-Strand RNA Viruses.Methods in molecular biology (Clifton, N.J.) · 2024
    Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Cost-Effectiveness and Impact of a Targeted Age- and Incidence-based West Nile Virus Vaccine Strategy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Article
  17. The Present and Future of Yellow Fever Vaccines.Pharmaceuticals (Basel, Switzerland) · 2021
    Review
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 3 countries.

Rex BiedenbenderThe Glennan Center for Geriatrics and Gerontology, Eastern Virginia Medical School, Norfolk, USA.
Joan Bevilacqua
Anne M Gregg
Mike Watson
Gustavo Dayan
Sanofi (United States) · USEastern Virginia Medical School · USSanofi (Canada) · CASanofi (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChimeriVax-WN02 is a live, attenuated chimeric vaccine for protection against West Nile virus. This Phase II, randomized, double-blind, placebo-controlled, multicenter study assessed the immunogenicity, viremia, and safety of the ChimeriVax-WN02 vaccine.

methodsThe 2-part study included adults in general good health. In part 1, subjects aged 18-40 years were randomized to 1 of 4 treatment groups: ChimeriVax-WN02 3.7- × -10(5) plaque-forming units (PFU), 3.7 × 10(4) PFU, 3.7 × 10(3) PFU, or placebo. In part 2, subjects aged 41-64 and ≥ 65 years were randomized to receive ChimeriVax-WN02 3.7 × 10(5) PFU or placebo.

resultsIn both part 1 and part 2, seroconversion was achieved at day 28 by >96% of subjects in active treatment groups. In part 1, neutralizing antibody titers at day 28 were higher and viremia levels lower with the highest dose, whereas the adverse event profile was similar between the dose groups. In part 2, antibody titers and viremia levels were higher in subjects aged ≥ 65 years, and more subjects in the 41-64 years cohort experienced adverse events.

conclusionsThe ChimeriVax-WN02 vaccine was highly immunogenic in younger adults and the elderly, and it was well tolerated at all dose levels and in all age groups investigated. Clinical Trials.gov identifier: NCT00442169.

Indexed as

AdolescentAdultAgedAntibodies, NeutralizingAntibodies, ViralDouble-Blind MethodFemaleHuman ExperimentationHumansMaleMiddle AgedPlacebosVaccines, AttenuatedViremiaWest Nile Virus VaccinesYoung AdultAntibodies, NeutralizingAntibodies, ViralChimeriVaxPlacebosVaccines, AttenuatedWest Nile Virus Vaccines

Identifiers

PMID21148499
PMCPMC3086439
OpenAlexW2010305470

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.