第二次接种NVX‐CoV2373新冠疫苗后血管水肿样眼睑水肿

IF 1.1 Q4 ALLERGY
Mari Matsumoto MD, Yoshio Kawakami MD, PhD, Tomoko Miyake MD, PhD, Yoji Hirai MD, PhD, Hitomi Kataoka MD, PhD, Fumio Otsuka MD, PhD, Shin Morizane MD, PhD
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Treatment with oral fexofenadine hydrochloride, introduced on day +5, was insufficient to suppress the skin lesions, and swelling of eyelids appeared on day +6 (Figure 1A). The patient was referred to our department on day +7. There was no family history of skin diseases and her medical history was unremarkable except for 2-year history of fibromyalgia and migraine, which were treated with celecoxib, duloxetine, lomerizine hydrochloride, and Japanese herbal medicines. Physical examination revealed swelling of eyelids with erythema extending to the forehead, a circumscribed erythema on the chin, and an edematous erythema on the right ear (Figure 1B,C), whereas the eruption on the left ear subsided and the vaccination site on the left arm was unaffected. Similarly, there was no swelling of the axillary lymph nodes at the injection site. 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引用次数: 0

摘要

NVX-CoV2373 (Novavax)是一种针对严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)的蛋白疫苗,由重组全长、稳定的预融合刺突蛋白同源三聚体组成,基于与中心聚山梨酸酯-80胶束的疏水相互作用,形成约30 nm的纳米颗粒一项针对成年参与者的双剂量NVX-CoV2373方案对SARS-CoV-2感染的保护作用达到89.7%,评估其对Omicron变体的有效性的研究正在进行中我们报告一例NVX-CoV2373冠状病毒病2019 (COVID-19)疫苗接种后出现血管性水肿样眼睑水肿。一名43岁妇女在第二次接种NVX-CoV2373疫苗后第2天发现左耳瘙痒性水肿疹(所有日期数字均指第二次剂量)。第5天口服盐酸非索非那定治疗不足以抑制皮肤病变,第6天出现眼睑肿胀(图1A)。患者于第7天转诊至我科。无皮肤病家族史,除纤维肌痛和偏头痛2年病史外,病史无明显差异。既往给予塞来昔布、度洛西汀、盐酸美嗪及日本中草药治疗。体格检查显示眼睑肿胀,红斑延伸至前额,下巴有边界红斑,右耳有水肿红斑(图1B,C),而左耳的皮疹消退,左臂的接种部位未受影响。同样,注射部位腋窝淋巴结未见肿大。实验室检查结果显示:白细胞计数正常,4810/μL,中性粒细胞74.9%,嗜酸性粒细胞1.0%,血清c反应蛋白(CRP)为0.17 mg/dL,血浆d -二聚体为1.4 μg/mL,而血清抗核抗体、免疫球蛋白E和补体水平,如补体3 (C3)、C4和总补体溶血活性(CH50)均在正常范围内。患者一般情况稳定,无发热和呼吸困难。患者口服强的松龙15mg /天。一周后,皮肤病变几乎消失(图1D),血清CRP和血浆d -二聚体水平恢复正常。强的松龙在第13天逐渐减少,无复发迹象。这些临床和实验室特征与血管性水肿相似,在某些病例中显示CRP和d -二聚体水平升高NVX-CoV2373被认为是安全的,临床试验中严重不良事件的发生率与安慰剂组相似另一方面,最近对Novavax临床试验的研究发现了几例心肌炎或心包炎,1例血管性水肿,1例格林-巴利综合征NVX-CoV2373含有聚山梨酯-80,这是一种高抗原性的非离子洗涤剂,与聚乙二醇(大醇)交叉反应这些洗涤剂通常包含在各种日常用品中。因此,本病例可能因首次接种NVX-CoV2373疫苗而对聚山梨酯-80敏感,或因在日常生活中无意中接触聚山梨酯-80或聚乙二醇而致敏。由于与NVX-CoV2373相关的皮肤不良反应没有特征,因此对每个病例的详细描述很重要。作者声明无利益冲突。批准研究方案:本研究未涉及人类受试者。知情同意:获得患者的知情同意。注册处及注册编号:不适用。动物研究:不适用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Angioedema-like eyelid edema following the second NVX-CoV2373 COVID-19 vaccination

Angioedema-like eyelid edema following the second NVX-CoV2373 COVID-19 vaccination

NVX-CoV2373 (Novavax) is a protein-based vaccine targeting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and composed of recombinant full-length, stabilized prefusion spike protein homotrimers that form approximately 30-nm nanoparticles based on hydrophobic interaction with a central polysorbate-80 micelle.1 A two-dose regimen of the NVX-CoV2373 administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection,2 and studies evaluating its efficacy against Omicron variant are ongoing.3 Herein, we report a case displaying angioedema-like eyelid edema after NVX-CoV2373 coronavirus disease 2019 (COVID-19) vaccination.

A 43-year-old woman noticed a pruritic edematous eruption of the left ear on day +2 after the second NVX-CoV2373 vaccination (all date numbers refer to the second dose). Treatment with oral fexofenadine hydrochloride, introduced on day +5, was insufficient to suppress the skin lesions, and swelling of eyelids appeared on day +6 (Figure 1A). The patient was referred to our department on day +7. There was no family history of skin diseases and her medical history was unremarkable except for 2-year history of fibromyalgia and migraine, which were treated with celecoxib, duloxetine, lomerizine hydrochloride, and Japanese herbal medicines. Physical examination revealed swelling of eyelids with erythema extending to the forehead, a circumscribed erythema on the chin, and an edematous erythema on the right ear (Figure 1B,C), whereas the eruption on the left ear subsided and the vaccination site on the left arm was unaffected. Similarly, there was no swelling of the axillary lymph nodes at the injection site. Laboratory findings showed a normal white blood cell count of 4810/μL, 74.9% neutrophils, 1.0% eosinophils, and slightly increased levels of serum C-reactive protein (CRP) at 0.17 mg/dL and plasma D-dimer at 1.4 μg/mL, whereas serum antinuclear antibody, immunoglobulin E, and complement levels, such as complement 3 (C3), C4 and total complement hemolytic activity (CH50), were within normal ranges. The patient's general condition was otherwise stable without fever and dyspnea. The patient was treated with oral prednisolone 15 mg/day. One week later, the skin lesions almost resolved (Figure 1D) and serum CRP and plasma D-dimer levels normalized. The prednisolone was tapered off on day +13 without any signs of recurrence.

These clinical and laboratory features resembled angioedema, which demonstrated elevated levels of CRP and D-dimer in some cases.4 NVX-CoV2373 is considered safe and the incidence of serious adverse events in the clinical trials was similar to the placebo group.2 On the other hand, recent studies of Novavax clinical trials revealed several cases of myocarditis or pericarditis, one case of angioedema, and one case of Guillain-Barré syndrome.5 NVX-CoV2373 contains polysorbate-80, a high antigenic non-ionic detergent that is cross-reactive with polyethylene glycol (macrogol).6 These detergents are commonly included in various daily products. Therefore, there is a possibility that our case was sensitized to polysorbate-80 either from the first NVX-CoV2373 vaccination, or from unintentional exposures to polysorbate-80, or polyethylene glycol in daily life. Since cutaneous adverse reactions related to NVX-CoV2373 are not characterized, a detailed description of each individual case is important.

The authors declare no conflict of interest.

Approval of the research protocol: No human participant was involved in this study.

Informed Consent: Informed consent was obtained from the patient.

Registry and the Registration No.: Not applicable.

Animal Studies: Not applicable.

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