Evidence map›Paper›PMID 29514306›Full record

Trial reportThe Journal of infectious diseases2018

Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study.

Elizabeth T Rogawski, James A Platts-Mills, E Ross Colgate, Rashidul Haque, K Zaman, William A Petri, Beth D Kirkpatrick

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01375647 (Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh), which is not on this map. Cited by 35 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 6 pooled it
2.3field-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.

NCT01375647 phase3completednot on this map

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh

TypeinterventionalSponsorUniversity of VermontRan2011 to 2014Enrolled700ConditionsRotavirus Diarrhea, Vaccine Virus Shedding, Tropical EnteropathyArmsIPV (inactivated polio vaccine), Rotarix
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 6 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Pooled it
  4. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019
    Pooled it
  5. Pooled it
  6. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019
    Pooled it
  7. Etiology and Incidence of Moderate-to-Severe Diarrhea in Young Children in Niger.Journal of the Pediatric Infectious Diseases Society · 2021
    Trial
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  10. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Elizabeth T RogawskiDepartment of Public Health Sciences, University of Virginia, Charlottesville.
James A Platts-MillsDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville.
E Ross ColgateDepartment of Medicine and Vaccine Testing Center, University of Vermont College of Medicine, Burlington.
Rashidul HaqueInternational Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
K ZamanInternational Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
William A PetriDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville.
Beth D KirkpatrickDepartment of Medicine and Vaccine Testing Center, University of Vermont College of Medicine, Burlington.
University of Virginia · USInternational Centre for Diarrhoeal Disease Research · BDUniversity of Vermont · US

Funding

VERMONT IMMUNOBIOLOIGY/ INFECTIOUS DISEASES CENTERP20RR021905 · NCRR · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI WARGO, MATTHEW J · 2006 to 2011
$14.5M
FIELD STUDIES OF IMMUNITY TO AMEBIASIS IN BANGLADESHR01AI043596 · NIAID · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI CAROL A GILCHRIST, William A Petri · 1998 to 2026
$7.7M
Vermont Immunology/Infectious Diseases CenterP30GM118228 · NIGMS · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI BUDD, RALPH C · 2016 to 2021
$6.8M
Quantitative molecular diagnostics for diarrhea etiology and vaccine efficacyK23AI114888 · NIAID · UNIVERSITY OF VIRGINIA · PI PLATTS-MILLS, JAMES ALEXANDER · 2015 to 2019
$932k
Translation of epidemiologic findings in enteric disease to public health actionK01AI130326 · NIAID · UNIVERSITY OF VIRGINIA · PI ROGAWSKI MCQUADE, ELIZABETH TACKET · 2018 to 2022
$612k
NCRR NIH HHS P20 RR021905NIAID NIH HHS K01 AI130326NIAID NIH HHS K23 AI114888NIAID NIH HHS R01 AI043596NIGMS NIH HHS P30 GM118228
6 · The paper itself

Abstract

Background: The low efficacy of rotavirus vaccines in clinical trials performed in low-resource settings may be partially explained by acquired immunity from natural exposure, especially in settings with high disease incidence. Methods: In a clinical trial of monovalent rotavirus vaccine in Bangladesh, we compared the original per-protocol efficacy estimate to efficacy derived from a recurrent events survival model in which children were considered naturally exposed and potentially immune after their first rotavirus diarrhea (RVD) episode. We then simulated trial cohorts to estimate the expected impact of prior exposure on efficacy estimates for varying rotavirus incidence rates and vaccine efficacies. Results: Accounting for natural immunity increased the per-protocol vaccine efficacy estimate against severe RVD from 63.1% (95% confidence interval [CI], 33.0%-79.7%) to 70.2% (95% CI, 44.5%-84.0%) in the postvaccination period, and original year 2 efficacy was underestimated by 14%. The simulations demonstrated that this expected impact increases linearly with RVD incidence, will be greatest for vaccine efficacies near 50%, and can reach 20% in settings with high incidence and low efficacy. Conclusions: High rotavirus incidence leads to predictably lower vaccine efficacy estimates due to the acquisition of natural immunity in unvaccinated children, and this phenomenon should be considered when comparing efficacy estimates across settings. Clinical Trials Registration: NCT01375647.

Indexed as

Immunity, InnateAntibodies, ViralBangladeshChild, PreschoolComputer SimulationHumansIncidenceInfantRotavirus InfectionsRotavirus VaccinesAntibodies, ViralRotavirus Vaccines

Identifiers

PMID29514306
PMCPMC5853827
OpenAlexW2791955517

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.