Machado Ketty Lysie Libardi Lira, Burian Ana Paula Neves, Martins-Filho Olindo Assis, Mill José Geraldo, Ferreira Lunara Baptista, Tapia Karina Rosemarie Lallemand, Moulin Anna Carolina Simões, Moulaz Isac Ribeiro, Ribeiro Priscila Dias Cardoso, Magalhães Vanessa de Oliveira, Biegelmeyer Erika, Peixoto Flávia Maria Matos Melo Campos, Ribeiro Sandra Lúcia Euzébio, Telles Camila Maria Paiva França, Bühring Juliana, Sartorio Natalia Sarzi, Hax Vanessa, Rezende Rodrigo Poubel Vieira de, Baptista Katia Lino, Melo Ana Karla Guedes de, Cruz Vitor Alves, Vieira Rejane Maria Rodrigues de Abreu, Azevedo Renata Henriques de, Azevedo Valderilio Feijó, Pinheiro Marcelo de Medeiros, Monticielo Odirlei André, Reis Neto Edgard Torres Dos, Teixeira-Carvalho Andréa, Xavier Ricardo Machado, Sato Emilia Inoue, de Souza Viviane Angelina, Ferreira Gilda Aparecida, Pileggi Gecilmara Salviato, Valim Valeria
Hospital Universitário Cassiano Antônio Moraes da Universidade Federal do Espírito Santo (HUCAM-UFES/EBSERH), Vitória 29041-295, ES, Brazil.
Centro de Referências para Imunobiológicos Especiais (CRIE) da Secretaria de Saúde do Estado do Espírito Santo, Vitória 29047-105, ES, Brazil.
Vaccines (Basel). 2024 Dec 3;12(12):1367. doi: 10.3390/vaccines12121367.
BACKGROUND/OBJECTIVES: The effectiveness of COVID-19 vaccine in patients with immune-mediated inflammatory diseases (IMID) depends on the underlying disease, immunosuppression degree and the vaccine regimens. We evaluate the safety and immunogenicity of different COVID-19 vaccine schedules.
The SAFER study: "Safety and effectiveness of the COVID-19 Vaccine in Rheumatic Disease", is a Brazilian multicentric prospective observational phase IV study in the real-life. Data were analyzed after 2 or 3 doses of COVID-19 vaccines: adenoviral vectored vaccine (ChAdOx1 nCoV-19, Astrazeneca), mRNA vaccine (BNT162b2, Pfizer-BioNTech) or inactivated SARS-COV-2 vaccine (CoronaVac, Sinovac Biotech). IgG antibody against SARS-CoV-2 spike (IgG-S) receptor-binding domain level were quantified at baseline (T1) and 28 days after the first (T2), 2nd (T3) and 3rd (T4) doses by chemiluminescence (SARS-CoV-2-IgG-II Quant-assay, Abbott-Laboratories).
721 patients with IMID were included in the analysis. The median titers of IgG-S (BAU/mL) increased progressively over the times: at baseline was 6.26 (5.41-7.24), T2: 73.01 (61.53-86.62), T3: 200.0 (174.36-229.41) and T4: 904.92 (800.49-1022.97). The multivariate linear regression showed that greater IgG-S titers were associated with pre-exposure to COVID-19 ( < 0.001) and BNT162b2 booster vaccine ( < 0.001). Rituximab and immunosuppressant drugs were independent factors for low titers ( = 0.002, < 0.001, respectively). No serious adverse event was reported.
All platforms were safe and induced an increase in IgG-S antibodies. COVID-19 pre-exposure and BNT162b2 booster regimens were predictors of higher humoral immune responses, which is relevant in immunosuppressed populations. Immunosuppressants (mainly rituximab) predicted the lowest antibodies.
背景/目的：新型冠状病毒肺炎（COVID-19）疫苗在免疫介导的炎症性疾病（IMID）患者中的有效性取决于基础疾病、免疫抑制程度和疫苗接种方案。我们评估了不同COVID-19疫苗接种方案的安全性和免疫原性。
SAFER研究：“COVID-19疫苗在风湿性疾病中的安全性和有效性”，是一项巴西多中心前瞻性观察性IV期真实世界研究。在接种2剂或3剂COVID-19疫苗后分析数据：腺病毒载体疫苗（ChAdOx1 nCoV-19，阿斯利康）、mRNA疫苗（BNT162b2，辉瑞-生物新技术公司）或灭活严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗（科兴新冠疫苗，科兴生物）。通过化学发光法（SARS-CoV-2-IgG-II定量检测，雅培实验室）在基线（T1）以及第1剂（T2）、第2剂（T3）和第3剂（T4）接种后28天对针对SARS-CoV-2刺突蛋白（IgG-S）受体结合域水平的IgG抗体进行定量。
721例IMID患者纳入分析。IgG-S（BAU/mL）的中位滴度随时间逐渐升高：基线时为6.26（5.41 - 7.24），T2时为73.01（61.53 - 86.62），T3时为200.0（174.36 - 229.41），T4时为904.92（800.49 - 1022.97）。多变量线性回归显示，较高的IgG-S滴度与COVID-19暴露前（<0.001）和BNT162b2加强疫苗（<0.001）相关。利妥昔单抗和免疫抑制药物是低滴度的独立影响因素（分别为=0.002，<0.001）。未报告严重不良事件。
所有疫苗平台均安全且能诱导IgG-S抗体增加。COVID-19暴露前和BNT162b2加强接种方案是更高体液免疫反应的预测因素，这在免疫抑制人群中具有重要意义。免疫抑制剂（主要是利妥昔单抗）预示着最低的抗体水平。
