Lacson Eduardo, Argyropoulos Christos P, Manley Harold J, Aweh Gideon, Chin Andrew I, Salman Loay H, Hsu Caroline M, Johnson Doug S, Weiner Daniel E
medRxiv. 2021 Apr 13:2021.04.08.21254779. doi: 10.1101/2021.04.08.21254779.
Patients receiving maintenance dialysis represent a high risk, immune-compromised population with 15-25% COVID mortality rate who were unrepresented in clinical trials evaluated for mRNA vaccines' emergency use authorization.
All patients receiving maintenance dialysis that 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. We report seroresponse based on levels of immunoglobulin-G against the receptor binding domain of the S1 subunit of SARS-CoV-2 spike antigen (seropositive ≥2) using FDA-approved semi-quantitative chemiluminescent assay (ADVIA Centaur® XP/XPT COV2G).
Among 186 dialysis patients from 32 clinics in 8 states tested 23±8 days after receiving 2 vaccine doses, mean age was 68±12 years, with 47% women, 21% Black, 26% residents in long-term care facilities and 97% undergoing in-center hemodialysis. Overall seropositive rate was 165/186 (88.7%) with 70% at maximum titer and with no significant difference in seropositivity between BNT162b2/Pfizer (N=148) and mRNA-1273/Moderna (N=18) vaccines (88.1% vs. 94.4%, p=0.42). Among patients with COVID-19 history, seropositive rate was 38/38 (100%) with 97% at maximum titer.
Most patients receiving maintenance dialysis were seropositive after two doses of BNT162b2/Pfizer or mRNA-1273/Moderna vaccine. Early evidence suggests that vaccinated dialysis patients with prior COVID-19 develop robust antibody response. These results support an equitable and aggressive vaccination strategy for eligible dialysis patients, regardless of age, sex, race, ethnicity, or disability, to prevent the extremely high morbidity and mortality associated with COVID-19 in this high risk population.
In this retrospective observational evaluation of SARS-CoV-2 mRNA vaccine response defined by detectable levels of immunoglobulin-G against the receptor binding domain of the S1 subunit of SARS-CoV-2 spike antigen of ≥2 in serum of patients receiving maintenance dialysis, 165/186 (88.7%) were found to be seropositive (with 70% at maximum titer) at least 14 days after completing the second dose. No significant differences were observed by race or other subgroup or by vaccine manufacturer. Therefore, an equitable and aggressive vaccination strategy for all eligible maintenance dialysis patients, regardless of age, sex, race, ethnicity, or disability, is warranted to prevent the extremely high morbidity and mortality associated with COVID-19 in this high risk population.
接受维持性透析的患者是高危免疫功能低下人群，新冠病毒感染死亡率为15%-25%，在评估mRNA疫苗紧急使用授权的临床试验中未被纳入。
纳入所有接受维持性透析且接种了两剂严重急性呼吸综合征冠状病毒2（SARS-CoV-2）mRNA疫苗的患者，这些患者在第二剂接种后≥14天进行了抗体检测，检测结果记录在电子健康记录中，截至2021年3月18日。我们使用美国食品药品监督管理局（FDA）批准的半定量化学发光法（ADVIA Centaur® XP/XPT COV2G），根据针对SARS-CoV-2刺突抗原S1亚基受体结合域的免疫球蛋白G水平（血清阳性≥2）报告血清反应。
在来自8个州32家诊所的186名透析患者中，在接种2剂疫苗后23±8天进行检测，平均年龄为68±12岁，女性占47%，黑人占21%，长期护理机构居民占26%，97%接受中心血液透析。总体血清阳性率为165/186（88.7%），70%达到最高滴度，BNT162b2/辉瑞疫苗组（N=148）和mRNA-1273/莫德纳疫苗组（N=18）的血清阳性率无显著差异（88.1%对94.4%，p=0.42）。在有新冠病毒感染病史的患者中，血清阳性率为38/38（100%），97%达到最高滴度。
大多数接受维持性透析的患者在接种两剂BNT162b2/辉瑞或mRNA-1273/莫德纳疫苗后呈血清阳性。早期证据表明，既往感染过新冠病毒的透析患者接种疫苗后会产生强烈的抗体反应。这些结果支持对符合条件的透析患者采取公平且积极的疫苗接种策略，无论其年龄、性别、种族、民族或残疾状况如何，以预防这一高危人群中与新冠病毒感染相关的极高发病率和死亡率。
在这项回顾性观察性评估中，通过检测接受维持性透析患者血清中针对SARS-CoV-2刺突抗原S1亚基受体结合域的免疫球蛋白G水平≥2来定义SARS-CoV-2 mRNA疫苗反应，发现165/186（88.7%）的患者在完成第二剂接种至少14天后呈血清阳性（70%达到最高滴度）。在种族或其他亚组以及疫苗生产商之间未观察到显著差异。因此，有必要对所有符合条件的维持性透析患者采取公平且积极的疫苗接种策略，无论其年龄、性别、种族、民族或残疾状况如何，以预防这一高危人群中与新冠病毒感染相关的极高发病率和死亡率。
