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

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

Conditions

• Rheumatic Disease
• HIV Infections
• AIDS
• Safety Issues
• Immunogenicity
• COVID-19

Interventions

BIOLOGICAL

CoronaVac

CoronaVac (Sinovac Biotech Ltd., Beijing, China)

Sponsors & Collaborators

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Kallas, MD, PhD · University of Sao Paulo General Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-09

Primary Completion

2023-11-27

Completion

2024-03-22

Countries

• Brazil

Study Locations