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

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ClinicalTrials.gov Identifier: NCT04754698
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief 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 Sjögren'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


Condition or disease Intervention/treatment Phase
Rheumatic Disease HIV Infections AIDS Safety Issues Immunogenicity COVID-19 Biological: CoronaVac Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2067 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study consisting of 3 arms, all of which will receive CoronaVac: patients with rheumatic diseases, PLWHA, and healthy controls.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the CoronaVac Vacccine in Patients With Autoimmune Rheumatic Diseases and People Living With HIV/AIDS
Actual Study Start Date : February 9, 2021
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Patients with rhematic diseases
CoronaVac 2-dose schedule with 21-28-day interval
Biological: CoronaVac
CoronaVac (Sinovac Biotech Ltd., Beijing, China)

Patients with PLWHA
CoronaVac 2-dose schedule with 21-28-day interval
Biological: CoronaVac
CoronaVac (Sinovac Biotech Ltd., Beijing, China)

Healthy controls
CoronaVac 2-dose schedule with 21-28-day interval
Biological: CoronaVac
CoronaVac (Sinovac Biotech Ltd., Beijing, China)




Primary Outcome Measures :
  1. Immunogenicity 1 [ Time Frame: 69 days ]
    Presence of ≥30% of neutralizing activity of SARS-CoV-2 antibodies

  2. Immunogenicity 2 [ Time Frame: 69 days ]
    Seroconversion rate of anti-SARS-Cov-2 IgG antibodies



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • RA patients according to the classification criteria of the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR).
  • Patients with axial spondyloarthritis (ASAS criteria 2009) and psoriatic arthritis (CASPAR 2012 criteria).
  • SLE patients according to the SLICC classification criteria.
  • SSc patients according to the ACR preliminary criteria.
  • Patients with inflammatory myopathies according to the Bohan and Peter's criteria.
  • Patients with primary vasculitis.
  • Patients with pSS (2002 American-European Consensus group criteria and/or 2016 classification criteria of the EULAR/ACR.
  • Patients with primary APS (primary antiphospholipid syndrome) (Sydney classification criteria).
  • Patients with HIV-related illness.

Exclusion Criteria:

  • History of anaphylactic response to vaccine components.
  • Acute febrile illness.
  • Guillain-Barré syndrome, decompensated heart failure (class III or IV), demyelinating disease.
  • History of live virus vaccine up to 4 weeks before, virus vaccine inactivated up to 2 weeks before.
  • History of having received blood products up to 6 months before the study.
  • Individuals who do not accept to participate in the study and/or whose guardians do not agree to participate in the study.
  • Hospitalized patients.
  • Patients with severe conditions requiring hospitalization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754698


Contacts
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Contact: Bonfa, MD, PhD 55 11 30617492 eloisa.bonfa@hc.fm.usp.br

Locations
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Brazil
University of Sao Paulo General Hospital Recruiting
São Paulo, SP, Brazil, 05403000
Contact: Eloisa Bonfa    55 11 30617492    eloisa.bonfa@hc.fm.usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Chair: Kallas, MD, PhD University of Sao Paulo General Hospital
Publications:

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04754698    
Other Study ID Numbers: 42566621.0.0000.0068
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
CoronaVac
Vaccine
Rheumatic disease
Systemic lupus erythematosus
Rheumatoid arthritis
HIV
AIDS
Safety
Immunogenicity
COVID-19
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases