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Safety and Efficacy of the Covid-19 Vaccine in patients with autoimmune inflammatory rheumatic diseases

Safety and Efficacy of the Covid-19 Vaccine in patients with autoimmune inflammatory rheumatic diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049138
Enrollment
Unknown
Registered
2021-07-23
Start date
2021-01-04
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases, Inflammatory Disorder

Interventions

AIIRD:COVID-19 vaccine
HC:COVID-19 vaccine

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 67 Years

Inclusion criteria

Inclusion criteria: 1. AIIRD group: 1) Over 18 years old; 2) Patients with informed and voluntary enrollment; 3) Patients with autoimmune diseases or inflammatory diseases (including rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, vasculitis, Behcet syndrome, systemic sclerosis, antiphospholipid antibody syndrome, etc.) 4) Treatment with immunomodulator and/ or immunosuppressants. 2. Healthy controls: 1) Over 18 years old; 2) Patients with informed and voluntary enrollment; 3. Patients without autoimmune diseases or inflammatory diseases (including rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, vasculitis, Behcet syndrome, systemic sclerosis, antiphospholipid antibody syndrome, etc.) 4. Absence of treatment with immunomodulator and/ or immunosuppressants.

Exclusion criteria

Exclusion criteria: had a history of Covid-SARS-2 infection; Those with positive Covid-SARS-2 antibody or RNA test before vaccination.

Design outcomes

Primary

MeasureTime frame
Adverse reactions after the first, the second and the third dose;

Secondary

MeasureTime frame
SARS-CoV-2 specific antibodies;Covid-SARS-2 neutralizing antibodies;Immunophenotyping of peripheral blood mononuclear cells;

Countries

China

Contacts

Public ContactJing He

Peking University People's Hospital

Heijing1105@126.com+86 18611707347

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026