Immunogenicity of SARS-CoV-2 Vaccination Schedules Including a Booster Dose in Patients with Systemic Lupus Erythematosus: Data from a Prospective Multicenter Study
Authors: 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 
Published: January 2025

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.