Evidence map›Paper›PMID 38460680›Full record

Trial reportThe Journal of allergy and clinical immunology2024

A randomized double-blinded trial to assess recurrence of systemic allergic reactions following COVID-19 mRNA vaccination.

Muhammad B Khalid, Ellen Zektser, Eric Chu, Min Li, Joanna Utoh, Patrick Ryan, Hanna S Loving, Roa Harb, Robbie Kattappuram, Lindsay Chatman and 17 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of allergy and clinical immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.9field-weighted citation impact, top 15% 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

4 citing papers in PubMed, 5 citations in OpenAlex.

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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

27 authors at 6 institutions in 1 country.

Muhammad B KhalidFood Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Ellen ZektserFood Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Eric ChuClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, Md.
Min LiFood Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Joanna UtohFood Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Patrick RyanOffice of the Clinical Director, National Institute of Mental Health, National Institutes of Health, Bethesda, Md.
Hanna S LovingDepartment of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, Md.
Roa HarbDepartment of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, Md.
Robbie KattappuramInvestigational Drug Management and Research Section, Clinical Center, National Institutes of Health, Bethesda, Md.
Lindsay ChatmanFood Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Stella HartonoFood Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Estefania Claudio-EtienneFood Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Guangping SunFood Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Edward P FeenerKalVista Pharmaceuticals, Cambridge, Mass.
Zhongbo LiDivision of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina Chapel Hill, Chapel Hill, NC.
Samuel K LaiDivision of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina Chapel Hill, Chapel Hill, NC.
Quang LeDepartment of Internal Medicine, Division of Rheumatology, Allergy, and Immunology, Virginia Commonwealth University, Richmond, Va.
Lawrence B SchwartzDepartment of Internal Medicine, Division of Rheumatology, Allergy, and Immunology, Virginia Commonwealth University, Richmond, Va.
Jonathan J LyonsTranslational Allergic Immunopathology Unit, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Hirsh KomarowMast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Zhao-Hua ZhouOffice of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md.
Haniya RazaOffice of the Clinical Director, National Institute of Mental Health, National Institutes of Health, Bethesda, Md.
Maryland PaoOffice of the Clinical Director, National Institute of Mental Health, National Institutes of Health, Bethesda, Md.
Karen LakyFood Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Steven M HollandLaboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Erica BrittainBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Pamela A Frischmeyer-GuerrerioFood Allergy Research Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md. Electronic address: pamela.guerrerio@nih.gov.
National Institutes of Health · USNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health Clinical Center · USVirginia Commonwealth University · USFrederick National Laboratory for Cancer Research · USKalVista Pharmaceuticals (United States) · US

Funding

Immune Tolerance Network UM1 2023 SupplementUM1AI109565 · NIAID · BENAROYA RESEARCH INST AT VIRGINIA MASON · PI Mark S Anderson, Jane Hoyt Buckner · 2014 to 2026
$451.6M
Overcoming anti-PEG immunity to restore prolonged circulation and efficacy of PEGylated therapeuticsR01HL141934 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LAI, SAMUEL, ZAMBONI, WILLIAM C · 2018 to 2021
$2.7M
COVID vaccine-associated allergic reactionsZIAAI001336 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI FRISCHMEYER-GUERRERIO, PAMELA · 2021 to 2025
$1.9M
Intramural NIH HHS ZIA AI001336NHLBI NIH HHS R01 HL141934NIAID NIH HHS SI2 AI138586NIAID NIH HHS UM1 AI109565
6 · The paper itself

Abstract

backgroundSystemic allergic reactions (sARs) following coronavirus disease 2019 (COVID-19) mRNA vaccines were initially reported at a higher rate than after traditional vaccines.

objectiveWe aimed to evaluate the safety of revaccination in these individuals and to interrogate mechanisms underlying these reactions.

methodsIn this randomized, double-blinded, phase 2 trial, participants aged 16 to 69 years who previously reported a convincing sAR to their first dose of COVID-19 mRNA vaccine were randomly assigned to receive a second dose of BNT162b2 (Comirnaty) vaccine and placebo on consecutive days in a blinded, 1:1 crossover fashion at the National Institutes of Health. An open-label BNT162b2 booster was offered 5 months later if the second dose did not result in severe sAR. None of the participants received the mRNA-1273 (Spikevax) vaccine during the study. The primary end point was recurrence of sAR following second dose and booster vaccination; exploratory end points included biomarker measurements.

resultsOf 111 screened participants, 18 were randomly assigned to receive study interventions. Eight received BNT162b2 second dose followed by placebo; 8 received placebo followed by BNT162b2 second dose; 2 withdrew before receiving any study intervention. All 16 participants received the booster dose. Following second dose and booster vaccination, sARs recurred in 2 participants (12.5%; 95% CI, 1.6 to 38.3). No sAR occurred after placebo. An anaphylaxis mimic, immunization stress-related response (ISRR), occurred more commonly than sARs following both vaccine and placebo and was associated with higher predose anxiety scores, paresthesias, and distinct vital sign and biomarker changes.

conclusionsOur findings support revaccination of individuals who report sARs to COVID-19 mRNA vaccines. Distinct clinical and laboratory features may distinguish sARs from ISRRs.

Indexed as

BNT162 VaccineCOVID-19COVID-19 VaccinesImmunization, SecondarySARS-CoV-22019-nCoV Vaccine mRNA-1273AdolescentAdultAgedCross-Over StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedRecurrence2019-nCoV Vaccine mRNA-1273BNT162 VaccineCOVID-19 Vaccinesallergic reactionAnaphylaxisCOVID-19immunization stress-related responseISRRmRNAPEGvaccine

Identifiers

PMID38460680
PMCPMC11162316
OpenAlexW4392564595

What OpenQuestion holds

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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.