Evidence map›Paper›PMID 25711607›Full record

Trial reportThe American journal of tropical medicine and hygiene2015

The "Performance of Rotavirus and Oral Polio Vaccines in Developing Countries" (PROVIDE) study: description of methods of an interventional study designed to explore complex biologic problems.

Beth D Kirkpatrick, E Ross Colgate, Josyf C Mychaleckyj, Rashidul Haque, Dorothy M Dickson, Marya P Carmolli, Uma Nayak, Mami Taniuchi, Caitlin Naylor, Firdausi Qadri and 6 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2015. 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 80 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 5 pooled it
8.2field-weighted citation impact, top 2% 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

80 citing papers in PubMed, 5 syntheses or guidelines pooled it, 114 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2021
    Pooled it
  4. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019
    Pooled it
  5. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019
    Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Rotavirus-Specific Immunoglobulin A Responses Are Impaired and Serve as a Suboptimal Correlate of Protection Among Infants in Bangladesh.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Trial
  10. Trial
  11. Trial
  12. Trial
  13. Nonspecific Effects of Oral Polio Vaccine on Diarrheal Burden and Etiology Among Bangladeshi Infants.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017
    Trial
  14. Trial
  15. Article
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  17. Review
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  19. Review
  20. Article

20 more citing papers are in PubMed but not listed here.

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

16 authors at 1 institution in 1 country.

Beth D KirkpatrickDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh beth.kirkpatrick@med.uvm.edu.
E Ross ColgateDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh beth.kirkpatrick@med.uvm.edu.
Josyf C MychaleckyjDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
Rashidul HaqueDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
Dorothy M DicksonDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
Marya P CarmolliDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
Uma NayakDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
Mami TaniuchiDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
Caitlin NaylorDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
Firdausi QadriDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
Jennie Z MaDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
Masud AlamDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
Mary Claire WalshDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
Sean A DiehlDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
PROVIDE Study Teams
William A PetriDepartment of Medicine and Vaccine Testing Center, The University of Vermont College of Medicine, Burlington, Vermont; Departments of Medicine, The University of Virginia, Charlottesville, Virginia; The icddr,b, Dhaka, Bangladesh.
University of Virginia · US

Funding

Global Biothreats Training ProgramT32AI055432 · NIAID · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI CRISS, ALISON K, PETRI, WILLIAM A · 2003 to 2022
$4.0M
NIAID NIH HHS T32 AI055432
6 · The paper itself

Abstract

Oral vaccines appear less effective in children in the developing world. Proposed biologic reasons include concurrent enteric infections, malnutrition, breast milk interference, and environmental enteropathy (EE). Rigorous study design and careful data management are essential to begin to understand this complex problem while assuring research subject safety. Herein, we describe the methodology and lessons learned in the PROVIDE study (Dhaka, Bangladesh). A randomized clinical trial platform evaluated the efficacy of delayed-dose oral rotavirus vaccine as well as the benefit of an injectable polio vaccine replacing one dose of oral polio vaccine. This rigorous infrastructure supported the additional examination of hypotheses of vaccine underperformance. Primary and secondary efficacy and immunogenicity measures for rotavirus and polio vaccines were measured, as well as the impact of EE and additional exploratory variables. Methods for the enrollment and 2-year follow-up of a 700 child birth cohort are described, including core laboratory, safety, regulatory, and data management practices. Intense efforts to standardize clinical, laboratory, and data management procedures in a developing world setting provide clinical trials rigor to all outcomes. Although this study infrastructure requires extensive time and effort, it allows optimized safety and confidence in the validity of data gathered in complex, developing country settings.

Indexed as

Administration, OralAntibodies, ViralBangladeshChildChild, PreschoolCohort StudiesDeveloping CountriesFemaleHumansInfantMalePoliomyelitisPoliovirusPoliovirus Vaccine, OralPoliovirus VaccinesRotavirusAntibodies, ViralPoliovirus Vaccine, OralPoliovirus VaccinesRotavirus VaccinesVaccines, Attenuated

Identifiers

PMID25711607
PMCPMC4385767
OpenAlexW2313065703

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.