COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS

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A sample of 1254 patients with rheumatic diseases and 542 healthy controls matched for age and sex was calculated as follows. 1.A) Evaluation of patients with SLE compared to a healthy control group matched for age and sex. The investigators calculated 74 patients in each arm, which will be compared...

A sample of 1254 patients with rheumatic diseases and 542 healthy controls matched for age and sex was calculated as follows. 1.A) Evaluation of patients with SLE compared to a healthy control group matched for age and sex. The investigators calculated 74 patients in each arm, which will be compared independently to the healthy control group: 74 SLE patients treated with hydroxychloroquine alone; 74 SLE patients with mild immunosuppression (azathioprine or methotrexate and prednisone <10 mg/day); 74 patients with moderate to severe immunosuppression (mycophenolate mofetil or cyclophosphamide and/or prednisone >10 mg/day); 50 patients with belimumab (convenience sample). Total: 272 SLE patients and 74 healthy controls. 1.B) Evaluation of RA patients compared to healthy controls matched for age and sex. The investigators calculated 61 patients in each arm, which will be independently compared to the control group: 61 RA patients only with conventional synthetic disease-modifying drugs (DMARDs); 61 RA patients with biological disease-modifying drugs (bDMARDs) with anti-TNF (anti-tumor necrosis factor) action; 61 RA patients with bDMARDs with non-anti-TNF action and with impact on the production of immunoglobulins (abatacept and rituximab); 61 RA patients with bDMARDs with anti-IL-6 (anti-interleukin-6) action (tocilizumab) and synthetic drugs with anti-JAK (anti-janus kinase) action (tofacitinib). Total: 244 RA patients vs. 61 healthy controls. 1.C) Evaluation of the interruption of the use of methotrexate (MTX) for 4 weeks from the first dose of vaccination in RA patients. Inclusion: patients using MTX in a stable dose for at least 4 weeks, prednisone maximum dose of 7.5 mg/day, in association or not with other drugs, to be randomized in two arms: one that keeps the therapy stable and the other which suspends MTX for 4 weeks from the first dose. The investigators calculated 96 patients in each arm: 96 MTX patients who will not have their therapy changed; 96 MTX patients who will stop only MTX on the day of vaccination for 4 weekly applications. Total: 192 RA patients. 1.D) Evaluation of patients with AS/psoriatic arthritis compared to a healthy control group matched for age and sex. The investigators calculated 136 patients in each arm, 136 with synthetic DMARDs and 136 with bDMARDs, to be compared with 136 healthy controls matched for age and sex. Total: 272 patients with AS/psoriatic arthritis vs. 136 healthy controls. E) A convenience sample of 250 (50 in each group) patients with other rare rheumatic diseases (SSc, PM/DM, pSS, systemic vasculitis, and primary antiphospholipid antibody syndrome) being followed up in Rheumatology Division (HCFMUSP) will be vaccinated and matched using the pool of controls from the other samples. Controls: 271 healthy controls matched for age and sex will be included according to the need for controls for SLE (n = 74), RA (n = 61) and AS/psoriatic arthritis (n = 136) will be selected to receive the vaccine at HCFMUSP. PEOPLE LIVING WITH HIV/AIDS (PLWHA) The investigators considered the immunogenicity of the vaccine for Yellow Fever as a parameter in a previous study carried out by our group. The response found was p1 = 92% induction of neutralizing antibodies in PLWHA. Considering the 1:1 ratio between vaccinated and controls, alpha error of 5% with 80% power, the sample size will be 271 vaccinated in the PLWHA group and 271 in the control group, with an effect size of 0.25. Total population: 1254 ARD patients + 542 controls + 271 patients in PLWHA group = 2067 patients. In addition to a symptom diary (provided to research subjects on the 1st and 2nd vaccine doses), all patients and controls were instructed to contact the researchers by email, WhatsApp, and telephone in case of adverse effects or symptoms of COVID. In cases of suspected COVID, RT-PCR and genotyping are being performed.

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