Clinical Phenotypes of Immediate First-Dose Reactions to mRNA COVID-19: A Multicenter Latent Class Analysis,The Journal of Allergy and Clinical Immunology: In Practice

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Clinical Phenotypes of Immediate First-Dose Reactions to mRNA COVID-19: A Multicenter Latent Class Analysis
The Journal of Allergy and Clinical Immunology: In Practice ( IF 9.4 ) Pub Date : 2022-09-13 , DOI: 10.1016/j.jaip.2022.08.048
Cosby A Stone ₁ , Lacey B Robinson ₂ , Lily Li ₃ , Matthew S Krantz ₁ , Jason H Kwah ₄ , Gilbert Ortega ₅ , Christian Mancini ₆ , Anna R Wolfson ₇ , Rebecca R Saff ₇ , Upeka Samarakoon ₆ , David I Hong ₃ , Grace Koo ₁ , Timothy G Chow ₅ , Rebecca Gruchalla ₅ , Jane X Liao ₄ , John K Kuster ₄ , Christina Price ₄ , Catherine Ahola ₆ , David A Khan ₅ , Elizabeth J Phillips ₈ , Aleena Banerji ₇ , Kimberly G Blumenthal ₉

Affiliation

Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tenn.
Harvard Medical School, Boston, Mass; Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Mongan Institute, Massachusetts General Hospital, Boston, Mass.
Harvard Medical School, Boston, Mass; Division of Allergy and Clinical Immunology, Department of Medicine, Brigham and Women's Hospital, Boston, Mass.
Department of Internal Medicine, Section of Rheumatology, Allergy, and Immunology, Yale School of Medicine, New Haven, Conn.
Division of Allergy and Immunology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas.
Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Mongan Institute, Massachusetts General Hospital, Boston, Mass.
Harvard Medical School, Boston, Mass; Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass.
Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tenn; Department of Pharmacology, Vanderbilt University School of Medicine, Nashville, Tenn.
Harvard Medical School, Boston, Mass; Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Mass; Mongan Institute, Massachusetts General Hospital, Boston, Mass; Edward P. Lawrence Center for Quality and Safety, Massachusetts General Hospital, Boston, Mass.

Background

Although immediate potentially allergic reactions have been reported after dose 1 of mRNA coronavirus disease 2019 (COVID-19) vaccines, comprehensively defined subtypes have not been clearly distinguished.

Objective

To define distinct clinical phenotypes of immediate reactions after dose 1 of mRNA COVID-19 vaccination, and to assess the relation of clinical phenotype to mRNA COVID-19 vaccine second dose tolerance.

Methods

This retrospective study included patients with 1 or more potentially allergic symptoms or signs within 4 hours of receiving dose 1 of an mRNA COVID-19 vaccine and assessed by allergy/immunology specialists from 5 U.S. academic medical centers (January–June 2021). We used latent class analysis—an unbiased, machine-learning modeling method—to define novel clinical phenotypes. We assessed demographic, clinical, and reaction characteristics associated with phenotype membership. Using log-binomial regression, we assessed the relation between phenotype membership and second dose tolerance, defined as either no symptoms or mild, self-limited symptoms resolving with antihistamines alone. A sensitivity analysis considered second dose tolerance as objective signs only.

Results

We identified 265 patients with dose-1 immediate reactions with 3 phenotype clusters: (1) Limited or Predominantly Cutaneous, (2) Sensory, and (3) Systemic. A total of 223 patients (84%) received a second dose and 200 (90%) tolerated their second dose. Sensory cluster (all patients had the symptom of numbness or tingling) was associated with a higher likelihood of second dose intolerance, but this finding did not persist when accounting for objective signs.

Conclusions

Three novel clinical phenotypes of immediate-onset reactions after dose 1 of mRNA COVID-19 vaccines were identified using latent class analysis: (1) Limited or Predominantly Cutaneous, (2) Sensory, and (3) Systemic. Whereas these clinical phenotypes may indicate differential mechanistic etiologies or associations with subsequent dose tolerance, most individuals proceeding to their second dose tolerated it.

中文翻译：

对 mRNA COVID-19 的立即首剂反应的临床表型：多中心潜在类别分析

背景

尽管在 2019 年 mRNA 冠状病毒病 (COVID-19) 疫苗接种第 1 剂后立即出现了潜在的过敏反应，但尚未明确区分全面定义的亚型。

客观的

定义 mRNA COVID-19 疫苗接种第一剂后立即反应的不同临床表型，并评估临床表型与 mRNA COVID-19 疫苗第二剂耐受性的关系。

方法

这项回顾性研究包括在接受第 1 剂 mRNA COVID-19 疫苗后 4 小时内出现 1 种或多种潜在过敏症状或体征的患者，并由来自 5 个美国学术医学中心的过敏/免疫学专家进行评估（2021 年 1 月至 6 月）。我们使用潜在类别分析——一种无偏见的机器学习建模方法——来定义新的临床表型。我们评估了与表型成员相关的人口统计学、临床和反应特征。使用对数二项式回归，我们评估了表型成员与第二剂量耐受性之间的关系，定义为无症状或轻度、自限性症状仅用抗组胺药即可解决。敏感性分析仅将第二次剂量耐受性视为客观指标。

结果

我们确定了 265 名具有 3 种表型簇的第 1 剂即刻反应的患者：(1) 受限或主要皮肤反应，(2) 感觉反应，和 (3) 全身反应。共有 223 名患者 (84%) 接受了第二剂，200 名 (90%) 患者耐受了他们的第二剂。感觉群（所有患者都有麻木或刺痛的症状）与第二次剂量不耐受的可能性较高有关，但考虑到客观体征时，这一发现并没有持续存在。