Evidence map›Paper›PMID 27522159›Full record

Trial reportThe Journal of allergy and clinical immunology2017

Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective.

Brian P Vickery, Jelena P Berglund, Caitlin M Burk, Jason P Fine, Edwin H Kim, Jung In Kim, Corinne A Keet, Michael Kulis, Kelly G Orgel, Rishu Guo and 6 more

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

Trial report in The Journal of allergy and clinical immunology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00932828 (Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance), which is not on this map. Cited by 145 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
145citing papers in PubMed, 3 pooled it
27.0field-weighted citation impact, top 1% 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.

NCT00932828 phase2completednot on this map

Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study; Grant "Optimizing Tolerance Induction in Peanut Allergy: The DEVIL Study"

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2009 to 2017Enrolled37ConditionsFood HypersensitivityArmsPeanut oral immunotherapy
3 · Its place in the literature

Who cites it

145 citing papers in PubMed, 3 syntheses or guidelines pooled it, 388 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Dosing Reactions and Missed Doses Affect Peanut Oral Immunotherapy Outcomes.The journal of allergy and clinical immunology. In practice · 2026
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. CD8Nature communications · 2022
    Trial
  10. Trial
  11. Trial
  12. Trial
  13. Gastrointestinal Eosinophil Responses in a Longitudinal, Randomized Trial of Peanut Oral Immunotherapy.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2021
    Trial
  14. Trial
  15. Trial
  16. Trial
  17. High- and low-dose oral immunotherapy similarly suppress pro-allergic cytokines and basophil activation in young children.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2019
    Trial
  18. Trial
  19. Trial
  20. Taste aversion and adverse events contribute equally to OIT discontinuation in children: A real-world multi-allergen analysis.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026
    Observational

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 5 institutions in 1 country.

Brian P VickeryUniversity of North Carolina-Chapel Hill, Chapel Hill, NC.
Jelena P BerglundDuke University School of Medicine, Durham, NC.
Caitlin M BurkUniversity of North Carolina-Chapel Hill, Chapel Hill, NC.
Jason P FineUniversity of North Carolina-Chapel Hill, Chapel Hill, NC.
Edwin H KimUniversity of North Carolina-Chapel Hill, Chapel Hill, NC.
Jung In KimUniversity of North Carolina-Chapel Hill, Chapel Hill, NC.
Corinne A KeetJohns Hopkins School of Medicine, Baltimore, Md.
Michael KulisUniversity of North Carolina-Chapel Hill, Chapel Hill, NC.
Kelly G OrgelUniversity of North Carolina-Chapel Hill, Chapel Hill, NC.
Rishu GuoUniversity of North Carolina-Chapel Hill, Chapel Hill, NC.
Pamela H SteeleUniversity of North Carolina-Chapel Hill, Chapel Hill, NC.
Yamini V VirkudMassachusetts General Hospital, Boston, Mass.
Ping YeUniversity of North Carolina-Chapel Hill, Chapel Hill, NC.
Benjamin L WrightMayo Clinic, Scottsdale, Ariz.
Robert A WoodJohns Hopkins School of Medicine, Baltimore, Md.
A Wesley BurksUniversity of North Carolina-Chapel Hill, Chapel Hill, NC. Electronic address: wesley.burks@unc.edu.
University of North Carolina at Chapel Hill · USJohns Hopkins University · USDuke University · USMassachusetts General Hospital · USMayo Clinic in Arizona · US

Funding

Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
RESEARCH TRAINING IN ALLERGY AND CLINICAL IMMUNOLOGYT32AI007062 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI David B. Peden, John W. Sleasman · 1985 to 2026
$6.1M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)KL2TR001109 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$5.7M
Understanding the Mechanism of Mucosal ImmunotherapyR01AI068074 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BURKS, A. WESLEY · 2007 to 2016
$3.8M
Genetic and Environmental Determinants of Food AllergyK23AI103187 · NIAID · JOHNS HOPKINS UNIVERSITY · PI KEET, CORINNE · 2012 to 2016
$684k
Optimizing Tolerance Induction in Peanut Allergy: The DEVIL StudyK23AI099083 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI VICKERY, BRIAN · 2012 to 2015
$494k
NCATS NIH HHS KL2 TR001109NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR001117NCATS NIH HHS UL1 TR002489NIAID NIH HHS K23 AI099083NIAID NIH HHS K23 AI103187NIAID NIH HHS R01 AI068074NIAID NIH HHS T32 AI007062
6 · The paper itself

Abstract

backgroundOral immunotherapy (OIT) is an effective experimental food allergy treatment that is limited by treatment withdrawal and the frequent reversibility of desensitization if interrupted. Newly diagnosed preschool children may have clinical and immunological characteristics more amenable to treatment.

objectiveWe sought to test the safety, effectiveness, and feasibility of early OIT (E-OIT) in the treatment of peanut allergy.

methodsWe enrolled 40 children aged 9 to 36 months with suspected or known peanut allergy. Qualifying subjects reacted to peanut during an entry food challenge and were block-randomized 1:1 to receive E-OIT at goal maintenance doses of 300 or 3000 mg/d in a double-blinded fashion. The primary end point, sustained unresponsiveness at 4 weeks after stopping early intervention oral immunotherapy (4-SU), was assessed by double-blinded, placebo-controlled food challenge either upon achieving 4 prespecified criteria, or after 3 maintenance years. Peanut-specific immune responses were serially analyzed. Outcomes were compared with 154 matched standard-care controls.

resultsOf 40 consented subjects, 3 (7.5%) did not qualify. Overall, 29 of 37 (78%) in the intent-to-treat analysis achieved 4-SU (300-mg arm, 17 of 20 [85%]; 3000 mg, 12 of 17 [71%], P = .43) over a median of 29 months. Per-protocol, the overall proportion achieving 4-SU was 29 of 32 (91%). Peanut-specific IgE levels significantly declined in E-OIT-treated children, who were 19 times more likely to successfully consume dietary peanut than matched standard-care controls, in whom peanut-specific IgE levels significantly increased (relative risk, 19.42; 95% CI, 8.7-43.7; P < .001). Allergic side effects during E-OIT were common but all were mild to moderate.

conclusionsAt both doses tested, E-OIT had an acceptable safety profile and was highly successful in rapidly suppressing allergic immune responses and achieving safe dietary reintroduction.

Indexed as

Desensitization, ImmunologicAllergensAntigens, PlantArachisChild, PreschoolDouble-Blind MethodFemaleHumansImmunoglobulin EInfantMalePeanut HypersensitivityPlant ProteinsAllergensAntigens, PlantImmunoglobulin EPlant Proteinsdesensitizationearly interventionOral immunotherapypeanut allergyrandomized clinical trialsustained unresponsiveness

Identifiers

PMID27522159
PMCPMC5222765
OpenAlexW2491611941

What OpenQuestion holds

Textmetadata
LicenceTDM
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.