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Immunogenicity and safety of COVID-19 vaccines in SLE and rheumatoid arthritis patients

Immunogenicity and safety of COVID-19 vaccines in SLE and rheumatoid arthritis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20210917003
Enrollment
100
Registered
2021-09-17
Start date
2021-06-24
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

SLE RA Immunosuppresive agents Immunogenicity to SARS-CoV2 vaccination SLE RA Immunosuppressive therapy Humoral immune response Cellular immune response SARS-CoV-2 vaccine

Interventions

SLE patients who get vaccinated with COVID19 vaccine,RA patients who get vaccinated with COVID19 vaccine
Other,Other
SLE patients,RA patients

Sponsors

Ratchadapiseksompotch Fund, Faculty of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age 18-65 years old Diagnosis of SLE according to American College of Rheumatology (ACR) 1997 or The Systemic Lupus International Collaborating Clinics (SLICC) criteria or or EULAR/ACR classification Diagnosis of RA according to 2010 ACR and European League Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis

Exclusion criteria

Exclusion criteria: Pregnancy History of SARS-CoV-2 infection Receipt of covid-19 vaccine prior to study enrollment Severe extra-renal involvement of SLE Receipt of prednisolone > 20 mg/day Receipt of mycophenolate mofetil(MMF) > 1.5 g/day Receipt of azathioprine > 2 mg/kg/day Treatment with cyclophosphamide within 1 month Treatment with biologic agents within the past 6 months Severe SLE flare including: CNS involvement, Vasculitis, Nephritis, Platelet < 60,000, Hemolytic anemia: Hgb < 7 g/dL or decrease in Hgb > 3 g/dL Not receiving immunosuppressive treatment

Design outcomes

Primary

MeasureTime frame
Humoral immune response after COVID-19 vaccination 4 weeks after 2nd vaccination AntiRBD, sVNT

Secondary

MeasureTime frame
Cellular immune response after COVID-19 vaccination 4 weeks after 2nd vaccination ELISpot

Countries

Thailand

Contacts

Public ContactTheerada Assawasaksakul

Chulalongkorn University

theerada.azza@gmail.com0830730873

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026