Immunogenicity and Safety of Pfizer-BionTech COVID-19 vaccine as booster dose(s) in systemic lupus erythematosus and rheumatoid arthritis patients who have been vaccinated with either inactivated SARS-CoV-2 or viral-vector ChAdOx1 nCoV-19 COVID-19 vaccine

Phase 3

Active, not recruiting

• Conditions: SLE RA Immunosuppressive agents booster mRNA COVID-19 vaccinePfizer-BioNTech COVID-19 vaccine; SLE; RA; Immunosuppressive therapy; Humoral immune response; Cellular immune response; booster mRNA COVID-19 vaccine; Pfizer-BioNTech COVID-19 vaccine

• Registration Number: TCTR20211220004
• Lead Sponsor: Ratchadapiseksompotch Fund, Faculty of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-20
• Study Completion: 2022-10-13
• 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, who have been vaccinated with either inactivated SARS-CoV-2 or viral-vector ChAdOx1 nCoV-19 COVID-19 vaccine

Exclusion Criteria

Pregnancy, History of SARS-CoV-2 infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity outcomes Day 15 Humoral immune response,Immunogenicity outcomes Day 15 Cellular immune response,Safety and reactogenicity outcomes Within 14 days Frequency and grade of AEs

Secondary Outcome Measures

Name	Time	Method
Immunogenicity outcomes Day 15 neutralizing antibody,Immunogenicity outcomes Day 85 and 169 Humoral immune response,Disease activity Day 15, 85, 169 Change in disease activity in participant subset with Systemic Lupus Erythematosus (SLE) as measured by Thanou modified SELENA-SLEDAI Flare Index for Systemic Lupus Erythematosus (SLE) ,Disease activity Day 15, 85, 169 Change in disease activity in participant subset with Rheumatoid Arthritis (RA) as measured by Disease Activity Score 28 ESR (DAS28-ESR) or Clinical Disease Activity Index (CDAI)