COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS
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- STATUS
- Recruiting
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- End date
- Mar 1, 2023
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- participants needed
- 2067
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- sponsor
- University of Sao Paulo General Hospital
Summary
Patients with chronic rheumatic diseases (such as systemic lupus erythematosus [SLE], rheumatoid arthritis [RA], ankylosing spondylitis [AS], juvenile idiopathic arthritis [JIA], poly/dermatomyositis [PM/DM], systemic sclerosis [SSc], systemic vasculitis, and primary Sjgren's syndrome [pSS]) are particularly susceptible to infectious diseases due to autoimmune disorder itself and its treatment (immunosuppressive therapies). Similarly, people living with HIV/AIDS (PLWHA) are predisposed to infections by different agents.
The current 2019 Coronavirus Disease Pandemic-19 (COVID-19), caused by the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) began in December 2019 in Wuhan, China, and quickly became a global health and economic emergency by taking to an unprecedented burden on health systems around the world.
However, SARS-Cov-2 infection raised particular concern in patients with autoimmune rheumatic diseases (DRAI) since, due to chronic inflammatory immune dysregulation and the regular use of immunosuppressive drugs, these patients are considered to be at high risk of contracting SARS-CoV-2 and potentially evolving to a worse prognosis.
The overlap between the COVID-19 pandemic and the HIV/AIDS pandemic also poses an additional challenge, as the impact of co-infection is not yet fully known. The response to vaccines for other agents, however, has already been described as compromised in PLWHA.
Vaccination is the most effective preventive measure to control the spread of coronavirus and to reduce associated complications. Usually, live or attenuated vaccines are not recommended for patients with chronic rheumatic diseases using immunosuppressants. However, immunization with inactivated agents is strongly indicated, resulting, in general, in good immunogenicity and adequate vaccine safety, as well as without relevant deleterious effects on diseases.
Vaccine efficacy studies are needed to verify the immunogenicity of the vaccine against COVID-19 in immunosuppressed patients with rheumatological disease and those with HIV-related disease considering the risk of greater severity. In addition, it is important to assess the safety of the vaccine in this population as well as the possibility of reactivating the rheumatological disease itself.
The present study will evaluate the safety and immunogenicity of the CoronaVac (Coronavirus vaccine, Sinovac Biotech Ltd.) in patients with rheumatic diseases and PLWHA
Description
A sample of 1254 patients with rheumatic diseases and 271 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.
2. 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.
Details
| Condition | Rheumatism, HIV infection, Immunodeficiency, CONNECTIVE TISSUE DISEASE, Musculoskeletal Disease, AIDS, HIV/AIDS, AIDS and AIDS related infections, Dermatomyositis (Connective Tissue Disease), Safety Issues, Primary Immunodeficiency Disorders, Acquired Immune Deficiency Syndrome (AIDS - Pediatric), Immunogenicity, Connective Tissue Diseases, Musculoskeletal Diseases, HIV Infections, *COVID-19, Covid-19, rheumatic diseases, rheumatic, rheumatic disease, inflammatory rheumatism, collagen disorders, human immunodeficiency virus, hiv disease, acquired immunodeficiency syndrome (aids), sida, acquired immune deficiency syndrome (aids) |
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| Treatment | CoronaVac |
| Clinical Study Identifier | NCT04754698 |
| Sponsor | University of Sao Paulo General Hospital |
| Last Modified on | 1 April 2021 |
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