Journal Article

Immunogenicity and Safety According to Immunosuppressive Drugs and Different COVID-19 Vaccine Platforms in Immune-Mediated Disease: Data from SAFER Cohort

Martins-Filho, Olindo Assis, Baptista, Katia Lino, Telles, Camila Maria Paiva França, Cruz, Vitor Alves, Pinheiro, Marcelo de Medeiros, Mill, José Geraldo, Xavier, Ricardo Machado, Melo, Ana Karla Guedes de, Moulaz, Isac Ribeiro, Magalhães, Vanessa de Oliveira, Vieira, Rejane Maria Rodrigues de Abreu, Machado, Ketty Lysie Libardi Lira, Reis Neto, Edgard Torres Dos, de Souza, Viviane Angelina, Azevedo, Renata Henriques de, Ferreira, Gilda Aparecida, Sato, Emilia Inoue, Tapia, Karina Rosemarie Lallemand, Ferreira, Lunara Baptista, Moulin, Anna Carolina Simões, Valim, Valeria, Bühring, Juliana, Hax, Vanessa, Peixoto, Flávia Maria Matos Melo Campos, Sartorio, Natalia Sarzi, Biegelmeyer, Erika, Rezende, Rodrigo Poubel Vieira de, Ribeiro, Priscila Dias Cardoso, Teixeira-Carvalho, Andréa, Monticielo, Odirlei André, Pileggi, Gecilmara Salviato, Azevedo, Valderilio Feijó, Burian, Ana Paula Neves, Ribeiro, Sandra Lúcia Euzébio

2024

Overview

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. Methods: 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). Results: 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 (p < 0.001) and BNT162b2 booster vaccine (p < 0.001). Rituximab and immunosuppressant drugs were independent factors for low titers (p = 0.002, p < 0.001, respectively). No serious adverse event was reported. Conclusions: 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.

• Publisher: MDPI AG,MDPI
• Subject: Adenoviruses / autoimmune disorders / Brazil / Chemiluminescence / COVID-19 / COVID-19 vaccines / Diseases / Drug dosages / Drugs / Effectiveness / Ethics / Health aspects / humoral immunity / IgG antibody / Immune response / Immune response (humoral) / Immunogenicity / Immunoglobulin G / Immunosuppression / Immunosuppressive agents / Immunotherapy / Inflammatory diseases / Medical research / mRNA / Pandemics / Proteins / registries / Rheumatic diseases / Rheumatology / Rituximab / RNA / Safety / Severe acute respiratory syndrome coronavirus 2 / Thymus gland / United Kingdom / vaccine / Vaccines