Evidence map›Paper›PMID 31242963›Full record

ArticleVaccine2019

An online decision tree for vaccine efficacy trial design during infectious disease epidemics: The InterVax-Tool.

Steven E Bellan, Rosalind M Eggo, Pierre-Stéphane Gsell, Adam J Kucharski, Natalie E Dean, Richard Donohue, Matt Zook, W John Edmunds, Frank Odhiambo, Ira M Longini and 3 more

Abstract read
In one paragraph

Article in Vaccine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
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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.

Steven E BellanDepartment of Epidemiology and Biostatistics, University of Georgia, Athens, GA, USA; Center for Ecology of Infectious Diseases, University of Georgia, Athens, GA, USA. Electronic address: steve.bellan@uga.edu.
Rosalind M EggoDepartment of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: r.eggo@lshtm.ac.uk.
Pierre-Stéphane GsellWorld Health Organization, Geneva, Switzerland.
Adam J KucharskiDepartment of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.
Natalie E DeanDepartment of Biostatistics, University of Florida, Gainesville, FL, USA.
Richard DonohueDepartment of Geography, University of Kentucky, Lexington, KY, USA.
Matt ZookDepartment of Geography, University of Kentucky, Lexington, KY, USA.
W John EdmundsDepartment of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.
Frank OdhiamboKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Ira M LonginiDepartment of Biostatistics, University of Florida, Gainesville, FL, USA.
Marc BrissonCentre de recherche du CHU de Québec, Québec, Canada; Département de médecine sociale et préventive, Université Laval, Québec, Canada; Department of Infectious Disease Epidemiology, Imperial College, London, UK.
Barbara E MahonCenters for Disease Control and Prevention, Atlanta, Georgia, USA.
Ana Maria Henao-RestrepoWorld Health Organization, Geneva, Switzerland.

Funding

Understanding Transmission with Integrated Genetic and Epidemiologic InferenceU54GM111274 · NIGMS · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BEDFORD, TREVOR BC · 2014 to 2018
$12.5M
Methods for Evaluating Vaccine EfficacyR37AI032042 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI HALLORAN, M ELIZABETH · 2010 to 2019
$5.1M
Integrative Modeling of study design and transmission dynamics to infer epidemic drivers and inform decision-making: Applications to HIV and other emerging pathogensK01AI125830 · NIAID · UNIVERSITY OF TEXAS AT AUSTIN · PI BELLAN, STEVEN E · 2016 to 2018
$397k
Department of Health MR/S003975/1Medical Research Council MR/S003975/1NIAID NIH HHS K01 AI125830NIAID NIH HHS R37 AI032042NIGMS NIH HHS U54 GM111274Wellcome Trust 206250/Z/17/ZWorld Health Organization 001
6 · The paper itself

Abstract

backgroundLicensed vaccines are urgently needed for emerging infectious diseases, but the nature of these epidemics causes challenges for the design of phase III trials to evaluate vaccine efficacy. Designing and executing rigorous, fast, and ethical, vaccine efficacy trials is difficult, and the decisions and limitations in the design of these trials encompass epidemiological, logistical, regulatory, statistical, and ethical dimensions.

resultsTrial design decisions are complex and interrelated, but current guidance documents do not lend themselves to efficient decision-making. We created InterVax-Tool (http://vaxeval.com), an online, interactive decision-support tool, to help diverse stakeholders navigate the decisions in the design of phase III vaccine trials. InterVax-Tool offers high-level visual and interactive assistance through a set of four decision trees, guiding users through selection of the: (1) Primary Endpoint, (2) Target Population, (3) Randomization Scheme, and, (4) Comparator. We provide guidance on how key considerations - grouped as Epidemiological, Vaccine-related, Infrastructural, or Sociocultural - inform each decision in the trial design process.

conclusionsInterVax-Tool facilitates structured, transparent, and collaborative discussion of trial design, while recording the decision-making process. Users can save and share their decisions, which is useful both for comparing proposed trial designs, and for justifying particular design choices. Here, we describe the goals and features of InterVax-Tool as well as its application to the design of a Zika vaccine efficacy trial.

Indexed as

Clinical Trials as TopicCommunicable Disease ControlDecision TreesResearch DesignVaccinesWeb BrowserHumansZika VirusZika Virus InfectionVaccinesDecision support systemEmerging infectious diseasesEpidemicsOutbreaksPhase III trialPublic Health EmergencyScientific communicationVaccinesVaccine trial design

Identifiers

PMID31242963
PMCPMC6620503

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.