Evidence map›Paper›PMID 30473186›Full record

ArticleVaccine2018

Informing randomized clinical trials of respiratory syncytial virus vaccination during pregnancy to prevent recurrent childhood wheezing: A sample size analysis.

Corinne A Riddell, Niranjan Bhat, Louis J Bont, William D Dupont, Daniel R Feikin, Deshayne B Fell, Tebeb Gebretsadik, Tina V Hartert, Jennifer A Hutcheon, Ruth A Karron and 9 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% 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.

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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Asthma Inception: Epidemiologic Risk Factors and Natural History Across the Life Course.American journal of respiratory and critical care medicine · 2024
    Review
  3. Article
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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

19 authors at 15 institutions in 8 countries.

Corinne A RiddellDivision of Epidemiology & Biostatistics, University of California, Berkeley, 2121 Berkeley Way, Suite 5404, Berkeley, CA, USA.
Niranjan BhatCenter for Vaccine Innovation and Access, PATH, 2201 Westlake Ave, Seattle, WA, USA.
Louis J BontDepartment of Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Lundlaan 6, Utrecht, the Netherlands; The ReSViNET Foundation, Zeist, the Netherlands.
William D DupontDepartment of Biostatistics, Vanderbilt University School of Medicine, Suite 1100, Room 11119, 2525 West End Ave., Nashville, TN 37203-1741, USA.
Daniel R FeikinInitiative for Vaccine Research, World Health Organization, 20 Avenue Appia, Geneva, Switzerland.
Deshayne B FellSchool of Epidemiology and Public Health, University of Ottawa, Children's Hospital of Eastern Ontario (CHEO) Research Institute, 401 Smyth Road, CPCR, Room L-1154, Ottawa, Ontario K1H 8L1, Canada.
Tebeb GebretsadikCenter for Asthma Research, Vanderbilt University School of Medicine, Department of Biostatistics, 2525 West End Ave, Suite 11000, Nashville, TN 37203, USA.
Tina V HartertCenter for Asthma Research, Allergy, Pulmonary & Critical Care Medicine, Vanderbilt University School of Medicine, 2525 West End Ave, Suite 450, Nashville, TN 37203, USA.
Jennifer A HutcheonDepartment of Obstetrics & Gynaecology, University of British Columbia, Shaughnessy C408A, British Columbia Children's & Women's Hospital, 4500 Oak Street, Vancouver, British Columbia V6H 3N1, Canada.
Ruth A KarronCenter for Immunization Research, Johns Hopkins University, 624 N. Broadway, Suite 217, Baltimore, MD, 21205, USA.
Harish NairCentre for Global Health Research, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Medical School, Teviot Place, Edinburgh EH8 9AG, Scotland, United Kingdom.
Robert C ReinerDepartment of Global Health, University of Washington, 2301 5th Ave, Suite 600, Seattle, WA 98102, USA.
Ting ShiCentre for Global Health Research, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Medical School, Teviot Place, Edinburgh EH8 9AG, Scotland, United Kingdom.
Peter D SlyChild Health Research Centre, University of Queensland, 62 Graham St., South Brisbane, QLD 4101, Australia.
Renato T SteinPediatric Pulmonary Unit, Pontificia Univeridade Católica RS, Av. Ipiranga, 6690/420 Porto Alegre, Brazil.
Pingsheng WuDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, 2525 West End Ave, Suite 1130, Nashville, TN, USA.
Heather J ZarDepartment of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, Cape Town, South Africa; SA-Medical Research Council Unit on Child and Adolescent Health, University of Cape Town, 5th Floor ICH Building, Klipfontein Road, Cape Town, South Africa.
Justin R OrtizCenter for Vaccine Development, University of Maryland School of Medicine, 685 W. Baltimore St, Suite 480, Baltimore, MD, USA. Electronic address: jortiz@som.umaryland.edu.
WHO Technical Working Group on Respiratory Syncytial Virus Vaccination During Pregnancy to Prevent Recurrent Childhood Wheezing
Vanderbilt University · USUniversity of Edinburgh · GBJohns Hopkins University · USPontifícia Universidade Católica do Rio Grande do Sul · BRProgram for Appropriate Technology in Health · USSouth African Medical Research Council · ZAThe University of Queensland · AUUniversity of British Columbia · CAUniversity of California, Berkeley · USUniversity of Maryland, Baltimore · USUniversity of Ottawa · CAUniversity of Washington · USVanderbilt University Medical Center · USWilhelmina Children's Hospital · NLWorld Health Organization · CH

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundEarly RSV illness is associated with wheeze-associated disorders in childhood. Candidate respiratory syncytial virus (RSV) vaccines may prevent acute RSV illness in infants. We investigated the feasibility of maternal RSV vaccine trials to demonstrate reductions in recurrent childhood wheezing in general paediatric populations.

methodsWe calculated vaccine trial effect sizes that depended on vaccine efficacy, allocation ratio, rate of early severe RSV illness, risk of recurrent wheezing at age 3, and increased risk of RSV infection on recurrent wheezing. Model inputs came from systematic reviews and meta-analyses. For each combination of inputs, we estimated the sample size required to detect the effect of vaccination on recurrent wheezing.

resultsThere were 81 scenarios with 1:1 allocation ratio. Risk ratios between vaccination and recurrent wheezing ranged from 0.9 to 1.0 for 70% of the scenarios. Among the 57 more plausible scenarios, the lowest sample size required to detect significant reductions in recurrent wheezing was 6196 mother-infant pairs per trial arm; however, 75% and 47% of plausible scenarios required >31,060 and >100,000 mother-infant pairs per trial arm, respectively. Studies with asthma endpoints at age 5 will likely need to be larger. DISCUSSION: Clinical efficacy trials of candidate maternal RSV vaccines undertaken for licensure are unlikely to demonstrate an effect on recurrent wheezing illness due to the large sample sizes likely needed to demonstrate a significant effect. Further efforts are needed to plan for alternative study designs to estimate the impact of maternal RSV vaccine programs on recurrent childhood wheezing in general populations.

Indexed as

Randomized Controlled Trials as TopicRespiratory SoundsSample SizeAsthmaChildChild, PreschoolFemaleHumansInfantMaleMothersOdds RatioPregnancyPregnancy Complications, InfectiousRecurrenceResearch DesignRespiratory Syncytial Virus VaccinesAsthmaGlobal healthPregnantRespiratory syncytial virusVaccineWheeze

Identifiers

PMID30473186
PMCPMC6288067
OpenAlexW2900986193

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.