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

Active, not recruiting

• Conditions: SLERAImmunosuppresive agentsImmunogenicity to SARS-CoV2 vaccination; SLE; RA; Immunosuppressive therapy; Humoral immune response; Cellular immune response; SARS-CoV-2 vaccine

• Registration Number: TCTR20210917003
• Lead Sponsor: Ratchadapiseksompotch Fund, Faculty of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-17
• Study Completion: 2022-06-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Humoral immune response after COVID-19 vaccination 4 weeks after 2nd vaccination AntiRBD, sVNT

Secondary Outcome Measures

Name	Time	Method
Cellular immune response after COVID-19 vaccination 4 weeks after 2nd vaccination ELISpot