Evidence map›Paper›PMID 28132800›Full record

ArticleThe journal of allergy and clinical immunology. In practice

Preparation and Analysis of Peanut Flour Used in Oral Immunotherapy Clinical Trials.

Jelena P Berglund, Nicole Szczepanski, Anusha Penumarti, Ayeshia Beavers, Janelle Kesselring, Kelly Orgel, Bruce Burnett, A Wesley Burks, Michael Kulis

Abstract read
In one paragraph

Article in The journal of allergy and clinical immunology. In practice. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.9field-weighted citation impact, top 16% 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

15 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Trial
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  4. Irradiation does not impact the immunogenicity of food flours used for oral immunotherapy.The journal of allergy and clinical immunology. Global · 2026
    Article
  5. Article
  6. Article
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  9. Review
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  12. Blocking antibodies induced by peanut oral and sublingual immunotherapy suppress basophil activation and are associated with sustained unresponsiveness.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2019
    Article
  13. Review
  14. Article
  15. Reprograming immunity to food allergens.The Journal of allergy and clinical immunology · 2018
    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

9 authors at 2 institutions in 1 country.

Jelena P BerglundDuke Translational Medicine Institute, Duke University Medical Center, Durham, NC.
Nicole SzczepanskiDepartment of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Anusha PenumartiDepartment of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Ayeshia BeaversDepartment of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Janelle KesselringDepartment of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Kelly OrgelDepartment of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Bruce BurnettDuke Translational Medicine Institute, Duke University Medical Center, Durham, NC.
A Wesley BurksDepartment of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Michael KulisDepartment of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC. Electronic address: mike.kulis@unc.edu.
University of North Carolina at Chapel Hill · USDuke Medical Center · US

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Understanding the Mechanism of Mucosal ImmunotherapyR01AI068074 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BURKS, A. WESLEY · 2007 to 2016
$3.8M
NCATS NIH HHS UL1 TR001117NIAID NIH HHS R01 AI068074
6 · The paper itself

Abstract

backgroundOral immunotherapy (OIT) is an investigational therapeutic approach for the treatment of food allergies. Characterization of the drug product used in oral immunotherapy trials for peanut allergy has not been reported.

objectiveTo quantify relative amounts of the major peanut allergens and microbial load present in peanut flour used in OIT trials and assess whether these parameters change over a 12-month period. We also anticipate that this report will serve as a guide for investigators seeking to conduct OIT trials under Food and Drug Administration-approved Investigational New Drug applications.

methodsDensitometric scanning of Ara h 1 and Ara h 2 resolved on SDS-PAGE gels was used to assess allergen content in peanut flour extracts. Microbial testing was conducted on peanut flour under US Pharmacopeia guidelines for the presence of Escherichia coli, salmonella, yeast, mold, and total aerobic bacteria. In addition, aflatoxin was quantified in peanut flour. Reported results were obtained from 4 unique lots of peanut flour.

resultsRelative amounts of the major peanut allergens were similar between different lots of peanut flour and remained stable over a 12-month period. E coli and salmonella were absent from all lots of flour. Yeast, mold, total aerobic bacteria, and aflatoxin were within established US Pharmacopeia guidelines on all lots tested and remained within the criteria over a 12-month period.

conclusionsPeanut flour used as a drug product contains the major peanut allergens and has low levels of potentially harmful microbes. Both these parameters remain stable over a 12-month period.

Indexed as

ArachisDesensitization, Immunologic2S Albumins, PlantAflatoxinsAllergensAntigens, PlantBacteriaClinical Trials as TopicFlourFungiGlycoproteinsHumansMembrane ProteinsPeanut HypersensitivityPlant Proteins2S Albumins, PlantAflatoxinsAllergensAntigens, PlantAra h 1 protein, Arachis hypogaeaAra h II protein, Arachis hypogaeaGlycoproteinsMembrane ProteinsPlant ProteinsAra h 1Ara h 2Drug productMicrobial testingPeanut allergyPeanut flourPeanut oral immunotherapyStability testing

Identifiers

PMID28132800
PMCPMC5503789
OpenAlexW2581128748

What OpenQuestion holds

Textmetadata
LicenceTDM
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.