包括加强剂量的SARS-CoV-2疫苗接种方案在系统性红斑狼疮患者中的免疫原性：一项前瞻性多中心研究的数据
Immunogenicity of SARS-CoV-2 Vaccination Schedules Including a Booster Dose in Patients with Systemic Lupus Erythematosus: Data from a Prospective Multicenter Study.
作者信息
Sartori Natália Sarzi, Machado Ketty Lysie Libardi Lira, Miyamoto Samira Tatiyama, Pretti Flávia Zon, Gouveia Maria da Penha Gomes, de Oliveira Yasmin Gurtler Pinheiro, da Silva Vanezia Gonçalves, Faé Filipe, Burian Ana Paula Neves, Tapia Karina Rosemarie Lallemand, Moulin Anna Carolina Simões, Grillo Luiza Lorenzoni, Athayde Paula Dos Santos, Corona Helena da Silva, Ramos Sabrina de Souza, Peixoto Flávia Maria Matos Melo Campos, Ribeiro Priscila Dias Cardoso, Magalhães Vanessa de Oliveira, de Aguiar Mariana Freitas, Biegelmeyer Erika, Kayser Cristiane, de Souza Alexandre Wagner Silva, de Moura Castro Charlles Heldan, Bühring Juliana, Ribeiro Sandra Lúcia Euzébio, Oliveira Dos Santos Sérgio Henrique, Martins Clara Pinheiro, da Silva Rodrigues Jonathan Willian, Sousa Dias Marcos Mavignier, Dutra Bruna Guimarães, Telles Camila Maria Paiva França, Basualto Dias Samuel Elias, Rezende Rodrigo Poubel Vieira de, Baptista Katia Lino, Gaudio Rodrigo Cutrim, Melo Ana Karla Guedes de, da Silva Valéria Bezerra, Cruz Vitor Alves, Rêgo Jozelia, Vieira Rejane Maria Rodrigues de Abreu, Vieira Adah Sophia Rodrigues, Kakehasi Adriana Maria, Tavares Anna Carolina Faria Moreira Gomes, Carvalho Victória Dornelas Paz, Azevedo Renata Henriques de, Azevedo Valderilio Feijó, Martins-Filho Olindo Assis, Peruhype-Magalhães Vanessa, Gasparin Andrese Aline, Hax Vanessa, Valim Valéria, Ferreira Gilda Aparecida, Teixeira-Carvalho Andréa, Reis-Neto Edgard Torres Dos, Sato Emília Inoue, Pinheiro Marcelo de Medeiros, de Souza Viviane Angelina, Xavier Ricardo Machado, Pileggi Gecilmara Salviato, Monticielo Odirlei André
机构信息
Serviço de Reumatologia, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre 90010-150, RS, Brazil.
Hospital Universitário Cassiano Antônio Moraes (HUCAM), Universidade Federal do Espírito Santo (UFES), Vitória 29041-295, ES, Brazil.
出版信息
Vaccines (Basel). 2025 Jan 27;13(2):127. doi: 10.3390/vaccines13020127.
OBJECTIVE
To evaluate the humoral response to and impact of SARS-CoV-2 vaccination in patients with systemic lupus erythematosus in a multicenter cohort design.
METHODS
Data for this analysis were obtained from the Study of Safety, Effectiveness and Duration of Immunity after Vaccination against SARS-CoV-2 in Patients with Immune-Mediated Inflammatory Diseases (SAFER), a prospective, multicenter, phase IV, real-world study conducted across different regions of Brazil from June/2021 to March/2024. Patients aged >18 years with systemic lupus erythematosus (SLE) who received any one of the SARS-CoV-2 vaccines approved by the Brazilian health regulatory agency (CoronaVac [inactivated SARS-CoV-2 vaccine], ChAdOx-1 [AstraZeneca], or BNT162b2 [Pfizer-BioNTech]) were included. Immunogenicity was assessed in pre- and post-vaccination blood samples, and patients were monitored in person and remotely for the occurrence and severity of COVID-19.
RESULTS
Two hundred and thirty-five patients with SLE who had completed their vaccination schedules (two doses + booster dose) were included in this study. Most patients were female (89.3%) and had low disease activity or were in remission (72.4%); the majority were also on some form of immunosuppressive therapy (58.1%). One hundred and sixteen patients received two doses of CoronaVac followed by one dose of BNT162b2 (Pfizer-BioNTech) vaccine, eighty-seven received two doses of ChAdOx1-S (AstraZeneca) followed by one dose of BNT162b2 (Pfizer-BioNTech) vaccine, and thirty-two received three doses of BNT162b2 (Pfizer-BioNTech) vaccine. Twenty-eight cases of COVID-19, none meeting criteria for severe COVID-19, were recorded in patients with respiratory symptoms after the second dose of a SARS-CoV-2 vaccine. Regarding immunogenicity, an increase in seroconversion rate was observed following consecutive vaccine doses, with no difference between vaccination schedules, reaching 97.57% seropositivity after a booster dose. The geometric mean IgG titers differed between the different vaccination schedules after the first and the second vaccine dose, being lowest for the CoronaVac-based schedule, but titers were similar after the administration of a booster dose.
CONCLUSION
In patients with SLE, SARS-CoV-2 vaccines are immunogenic, inducing a robust humoral response. No severe outcomes associated with death or hospitalization were found in the evaluated patient sample. Complete vaccination schedules including a booster dose induced higher humoral responses than incomplete schedules, especially in patients initially immunized with an inactivated virus vaccine schedule and those with a suboptimal humoral response.
目的
在一项多中心队列设计中评估系统性红斑狼疮患者对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗的体液反应及影响。
方法
本分析的数据来自免疫介导的炎症性疾病患者接种SARS-CoV-2疫苗后的安全性、有效性和免疫持续时间研究（SAFER），这是一项于2021年6月至2024年3月在巴西不同地区进行的前瞻性、多中心、IV期真实世界研究。纳入年龄>18岁、接受过巴西卫生监管机构批准的任何一种SARS-CoV-2疫苗（科兴新冠疫苗[灭活SARS-CoV-2疫苗]、ChAdOx-1[阿斯利康]或BNT162b2[辉瑞-生物科技]）的系统性红斑狼疮（SLE）患者。在接种疫苗前后的血样中评估免疫原性，并对患者进行亲自和远程监测，以了解新冠病毒病（COVID-19）的发生情况和严重程度。
结果
本研究纳入了235名已完成疫苗接种程序（两剂+加强剂）的SLE患者。大多数患者为女性（89.3%），疾病活动度低或处于缓解期（72.4%）；大多数患者也在接受某种形式的免疫抑制治疗（58.1%）。116名患者接受了两剂科兴新冠疫苗，随后接种一剂BNT162b2（辉瑞-生物科技）疫苗，87名患者接受了两剂ChAdOx1-S（阿斯利康）疫苗，随后接种一剂BNT162b2（辉瑞-生物科技）疫苗，32名患者接受了三剂BNT162b2（辉瑞-生物科技）疫苗。在接种第二剂SARS-CoV-2疫苗后，有呼吸道症状的患者中记录到28例COVID-19病例，无一例符合重症COVID-19标准。关于免疫原性，连续接种疫苗后血清转化率增加，不同接种程序之间无差异，加强剂接种后血清阳性率达到97.57%。第一剂和第二剂疫苗接种后，不同接种程序的几何平均IgG滴度不同，基于科兴新冠疫苗的接种程序最低，但加强剂接种后滴度相似。
结论
在SLE患者中，SARS-CoV-2疫苗具有免疫原性，可诱导强烈的体液反应。在评估的患者样本中未发现与死亡或住院相关的严重后果。包括加强剂的完整疫苗接种程序比不完整程序诱导更高的体液反应，特别是在最初接种灭活病毒疫苗程序的患者和体液反应欠佳的患者中。
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