Evidence map›Paper›PMID 34174082›Full record

Trial reportThe Journal of infectious diseases2022

Analysis of Neutralizing Antibodies as a Correlate of Instantaneous Risk of Hospitalized Dengue in Placebo Recipients of Dengue Vaccine Efficacy Trials.

Ying Huang, Brian D Williamson, Zoe Moodie, Lindsay N Carpp, Laurent Chambonneau, Carlos A DiazGranados, Peter B Gilbert

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 35% 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.

NCT01373281 phase3completednot on this map

Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2011 to 2017Enrolled10,275ConditionsDengue, Dengue Fever, Dengue Hemorrhagic FeverArmsLive, attenuated, dengue serotype 1, 2, 3, 4 virus, Placebo: Sodium chloride (NaCl) 0.9%
NCT01374516 phase3completednot on this map

Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2011 to 2018Enrolled20,869ConditionsDengue Fever, Dengue Hemorrhagic Fever, DengueArmsLive, attenuated, dengue serotype 1, 2, 3, 4 virus, Placebo: (NaCl) 0.9% solution
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

7 authors at 4 institutions in 2 countries.

Ying HuangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.ORCID 0000-0002-9655-7502
Brian D WilliamsonVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Zoe MoodieVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Lindsay N CarppVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Laurent ChambonneauClinical Sciences, Sanofi Pasteur, Marcy-L'Etoile, France.
Carlos A DiazGranadosClinical Sciences, Sanofi Pasteur, Swiftwater, Pennsylvania, USA.
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Fred Hutch Cancer Center · USUniversity of Washington · USSanofi (France) · FRSanofi (United States) · US

Funding

SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
Statistical Methods in HIV Vaccine Efficacy TrialsR37AI054165 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert · 2010 to 2026
$6.7M
NIAID NIH HHS R37 AI054165NIAID NIH HHS UM1 AI068635
6 · The paper itself

Abstract

backgroundIn the CYD14 (NCT01373281) and CYD15 (NCT01374516) dengue vaccine efficacy trials, month 13 neutralizing antibody (nAb) titers correlated inversely with risk of symptomatic, virologically confirmed dengue (VCD) between month 13 (1 month after final dose) and month 25. We assessed nAb titer as a correlate of instantaneous risk of hospitalized VCD (HVCD), for which participants were continually surveilled for 72 months.

methodsUsing longitudinal nAb titers from the per-protocol immunogenicity subsets, we estimated hazard ratios (HRs) of HVCD by current nAb titer value for 3 correlate/endpoint pairs: average titer across all 4 serotypes/HVCD of any serotype (HVCD-Any), serotype-specific titer/homologous HVCD, and serotype-specific titer/heterologous HVCD.

resultsBaseline-seropositive placebo recipients with higher average titer had lower instantaneous risk of HVCD-Any in 2- to 16-year-olds and in 9- to 16-year-olds (HR, 0.26 or 0.15 per 10-fold increase in average titer by 2 methods [95% confidence interval {CI}, .14-.45 and .07-.34, respectively]) pooled across both trials. Results were similar for homologous HVCD. There was evidence suggesting increased HVCD-Any risk in participants with low average titer (1:10 to 1:100) compared to seronegative participants (HR, 1.85 [95% CI, .93-3.68]).

conclusionsNatural infection-induced nAbs were inversely associated with hospitalized dengue, upon exceeding a relatively low threshold.

Indexed as

Antibodies, NeutralizingVaccine EfficacyAdolescentAntibodies, ViralChildChild, PreschoolDengueDengue VaccinesDengue VirusFemaleFollow-Up StudiesHospitalizationHumansMaleAntibodies, NeutralizingAntibodies, ViralDengue VaccinesCYD-TDVhospitalized dengueimmune correlatesmultiple imputationneutralizing antibodiestetravalent dengue vaccinetime-varying correlates

Identifiers

PMID34174082
PMCPMC8915240
OpenAlexW3174171600

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.