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血液透析患者的 SARS-CoV-2 疫苗免疫原性。

Immunogenicity of SARS-CoV-2 Vaccine in Dialysis.

机构信息

Division of Nephrology, Tufts Medical Center, Boston, Massachusetts.

Dialysis Clinic, Inc., Nashville, Tennessee.

出版信息

J Am Soc Nephrol. 2021 Nov;32(11):2735-2742. doi: 10.1681/ASN.2021040432. Epub 2021 Aug 4.

Abstract

BACKGROUND

Patients receiving maintenance dialysis represent a high-risk, immune-compromised population with 15%-25% COVID-19 mortality rate who were unrepresented in clinical trials of mRNA vaccines.

METHODS

All patients receiving maintenance dialysis who received two doses of SARS-CoV-2 mRNA vaccines with antibody test results drawn ≥14 days after the second dose, as documented in the electronic health record through March 18, 2021, were included. Response was on the basis of levels of Ig-G against the receptor binding domain of the S1 subunit of SARS-CoV-2 spike-antigen (seropositive ≥2 U/L) using an FDA-approved semiquantitative chemiluminescent assay (ADVIA Centaur XP/XPT COV2G).

RESULTS

Among 186 patients on dialysis from 30 clinics in eight states tested 23±8 days after receiving two vaccine doses, there were 165 (88.7%) responders with 70% at maximum titer. There was no significant difference between BNT162b2/Pfizer (148 out of 168, 88.1%) and mRNA-1273/Moderna (17 out of 18, 94.4%), =0.42. All 38 patients with COVID-19 history were responders, with 97% at maximum titer. Among patients without COVID-19, 127 out of 148 (85.8%) were responders, comparable between BNT162b2/Pfizer (113 out of 133) and mRNA-1273/Moderna (14 out of 15) vaccines (85.0% versus 93.3%, =0.38).

CONCLUSIONS

Most patients receiving maintenance dialysis responded after two doses of BNT162b2/Pfizer or mRNA-1273/Moderna vaccine, suggesting the short-term development of antispike antibody is good, giving hope that most of these patients who are vulnerable, once immunized, will be protected from COVID-19. Longer-term evaluation is needed to determine antibody titer durability and if booster dose(s) are warranted. Further research to evaluate the approach to patients without a serologic response is needed, including benefits of additional dose(s) or administration of alternate options.

摘要

背景

接受维持性透析的患者代表了一个高风险、免疫功能受损的人群,他们的 COVID-19 死亡率为 15%-25%,并且在 mRNA 疫苗的临床试验中没有代表性。

方法

所有接受过两剂 SARS-CoV-2 mRNA 疫苗且在第二剂后至少 14 天在电子健康记录中记录了抗体检测结果的接受维持性透析的患者均被纳入研究。反应基于针对 SARS-CoV-2 刺突抗原 S1 亚单位受体结合域的 IgG 水平(血清阳性≥2 U/L),使用 FDA 批准的半定量化学发光分析(ADVIA Centaur XP/XPT COV2G)。

结果

在从八个州的 30 个诊所中接受两剂疫苗后 23±8 天接受测试的 186 名透析患者中,有 165 名(88.7%)为应答者,其中 70%达到最大滴度。BNT162b2/辉瑞(168 名中的 148 名,88.1%)和 mRNA-1273/Moderna(18 名中的 17 名,94.4%)之间没有显著差异,=0.42。所有 38 名有 COVID-19 病史的患者均为应答者,其中 97%达到最大滴度。在没有 COVID-19 病史的患者中,127 名(148 名中的 85.8%)为应答者,BNT162b2/辉瑞(113 名中的 133 名)和 mRNA-1273/Moderna(14 名中的 15 名)疫苗之间没有差异(85.0%比 93.3%,=0.38)。

结论

大多数接受维持性透析的患者在接受两剂 BNT162b2/辉瑞或 mRNA-1273/Moderna 疫苗后产生了应答,这表明短期产生的抗刺突抗体良好,这给了我们希望,即这些脆弱的患者一旦免疫,将免受 COVID-19 的侵害。需要进行更长期的评估以确定抗体滴度的持久性以及是否需要加强剂量。需要进一步研究评估对无血清学反应的患者的方法,包括额外剂量的益处或替代方案的使用。

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