Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial

Abstract

evere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected millions of people around the world 1 . Brazil is among those countries with the highest numbers of confirmed cases of, and deaths from, SARS-CoV-2 (refs. 1,2 ), with >430,000 deaths registered and approximately 15 million cases as of May 2021 (ref. 1 ). A second infection wave was driven by the Gamma coronavirus variant 3 , which is considered to be 2.5-fold more contagious than the original strain 4 and possibly associated with a higher risk for hospitalization and intensive care unit admission in patients younger than 60 years of age 5 . This second peak in March and April 2021 resulted in more than double the reported coronavirus disease 2019 (COVID-19) cases of the first peak in 2020 (ref. 6 ). Vaccines are therefore essential in regard to reducing COVID-19 mortality and morbidity.Although phase 3 clinical trials results are still being consolidated in China,

Physical activity associates with enhanced immunogenicity of an inactivated virus vaccine against SARS-CoV-2 in patients with autoimmune rheumatic diseases

“…However, vaccine e cacy varies between individuals, with particularly low responses found in those with reduced immune function. 14,15 mRNA vaccines against SARS-CoV-2 can elicit a reduced humoral response in older individuals and in ARD patients, [4][5][6]16 a nding recently extended to CoronaVac, 9 which has been largely used in highly populated countries, and recently approved for emergency use by WHO. 17 Indeed, previous data from this trial point out to lower SC (70.4 vs. 95.5%) and titers (12.1 vs. 29.7), frequency of NAb positivity (56.3 vs.…”

“…79.3%) and neutralization activity (58.7 vs. 64.5%) in ARD patients vs. controls. 9 It becomes clear that the search for adjuvants to enhance vaccine response and improve protection from disease infection is of great clinical importance. Chief amongst these is physical activity, which has been deemed as a behavioral intervention able to boost immune function in different scenarios, thereby potentially serving as an adjuvant to improve vaccine response, including that against SARS-CoV-2.…”

“…Participants ARD patients aged ≥ 18 years and diagnosed with rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, psoriatic arthritis, primary vasculitis, primary Sjögren's syndrome, systemic sclerosis, systemic autoimmune myopathies and primary antiphospholipid syndrome, following previously reported criteria. 9 Additionally, a group of individuals without ARD, HIV or other conditions requiring immunosuppressive therapy were also studied. Exclusion criteria were: history of anaphylactic response to vaccine components, acute febrile illness or symptoms compatible to COVID-19 at vaccination, Guillain-Barré syndrome, decompensated heart failure (class III or IV), demyelinating disease, previous vaccination with any SARS-CoV-2 vaccine, history of live virus vaccine up to four weeks before, inactivated virus vaccine up to two weeks before, and receipt of blood products up to six months before the study, hospitalized patients, and pre-vaccination COVID-19 assessed by anti-SARS-CoV-2 S1/S2 IgG and/or neutralizing antibodies (NAb).…”

“…Participants who had RT-PCR-con rmed COVID-19 after receiving 1st vaccine dose were excluded. 9 Vaccination Participants underwent a two-dose schedule of CoronaVac (Sinovac Life Sciences, Beijing, China, batch #20200412) as previously described. 9 The 1st dose was administered on February 9-10, 2021 (D0) and the 2nd dose was given on March 9-10, 2021 (D28).…”

“…9 Vaccination Participants underwent a two-dose schedule of CoronaVac (Sinovac Life Sciences, Beijing, China, batch #20200412) as previously described. 9 The 1st dose was administered on February 9-10, 2021 (D0) and the 2nd dose was given on March 9-10, 2021 (D28). Blood samples (20mL) from all participants were obtained at D0, D28, and D69 (six weeks after 2nd dose) at the Hospital Convention Center.…”