Evidence map›Paper›PMID 34741103›Full record

Trial reportScientific reports2021

Oral rotavirus vaccine shedding as a marker of mucosal immunity.

Benjamin Lee, Md Abdul Kader, E Ross Colgate, Marya Carmolli, Dorothy M Dickson, Sean A Diehl, Masud Alam, Sajia Afreen, Josyf C Mychaleckyj, Uma Nayak and 3 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.5field-weighted citation impact, top 32% 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

9 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
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 at 3 institutions in 2 countries.

Benjamin LeeTranslational Global Infectious Diseases Research Center, Larner College of Medicine, University of Vermont, 95 Carrigan Drive, Stafford 208, Burlington, VT, 05405, USA. blee7@uvm.edu.
Md Abdul KaderInternational Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
E Ross ColgateTranslational Global Infectious Diseases Research Center, Larner College of Medicine, University of Vermont, 95 Carrigan Drive, Stafford 208, Burlington, VT, 05405, USA.
Marya CarmolliDepartment of Microbiology and Molecular Genetics, Larner College of Medicine, University of Vermont, Burlington, VT, USA.
Dorothy M DicksonTranslational Global Infectious Diseases Research Center, Larner College of Medicine, University of Vermont, 95 Carrigan Drive, Stafford 208, Burlington, VT, 05405, USA.
Sean A DiehlDepartment of Microbiology and Molecular Genetics, Larner College of Medicine, University of Vermont, Burlington, VT, USA.
Masud AlamInternational Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
Sajia AfreenInternational Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
Josyf C MychaleckyjCenter for Public Health Genomics and Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.
Uma NayakCenter for Public Health Genomics and Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.
William A PetriDivision of Infectious Diseases and International Health, University of Virginia, Charlottesville, VA, USA.
Rashidul HaqueInternational Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
Beth D KirkpatrickTranslational Global Infectious Diseases Research Center, Larner College of Medicine, University of Vermont, 95 Carrigan Drive, Stafford 208, Burlington, VT, 05405, USA.
University of Vermont · USInternational Centre for Diarrhoeal Disease Research · BDUniversity of Virginia · US

Funding

Using Dengue Controlled Human Infection Model to Identify Adaptive Immune Correlates of ProtectionP20GM125498 · NIGMS · UNIVERSITY OF VERMONT & ST AGRIC COLLEGE · PI Ellen Kozelka · 2018 to 2026
$24.9M
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
Bill and Melinda Gates Foundation OPP1127782NIAID NIH HHS R01 AI043596NIGMS NIH HHS P20 GM125498
6 · The paper itself

Abstract

Group A rotaviruses (RVA) remain a leading cause of pediatric diarrhea worldwide, in part due to underperformance of currently approved live-attenuated, oral vaccines in low-and-middle income countries. Improved immune correlates of protection (CoP) for existing oral vaccines and novel strategies to evaluate the performance of next-generation vaccines are needed. Use of oral vaccines as challenge agents in controlled human infection models is a potential approach to CoP discovery that remains underexplored. In a live-attenuated, oral rotavirus vaccine (Rotarix, GlaxoSmithKline) efficacy trial conducted among infants in Dhaka, Bangladesh, we explored the potential for the second dose of the two-dose series to be considered a challenge agent through which RVA immunity could be explored, using fecal virus shedding post-dose 2 as a marker of mucosal immunity. Among 180 vaccinated infants who completed the parent study per protocol, the absence of fecal vaccine shedding following the second dose of Rotarix suggested intestinal mucosal immunity generated by the first dose and a decreased risk of RVA diarrhea through 2 years of life (RR 0.616, 95% CI 0.392-0.968). Further development of controlled human infection models for group A rotaviruses, especially in prospective studies with larger sample sizes, may be a promising tool to assess rotavirus vaccine efficacy and CoPs.

Indexed as

Immunity, MucosalAdministration, OralCohort StudiesFecesHumansInfantRotavirusRotavirus InfectionsRotavirus VaccinesVaccines, AttenuatedRIX4414 vaccineRotavirus VaccinesVaccines, Attenuated

Identifiers

PMID34741103
PMCPMC8571310
OpenAlexW3193903094

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.