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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211220004
Enrollment
100
Registered
2021-12-20
Start date
2021-10-14
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 Immunosuppressive agents booster mRNA COVID-19 vaccine Pfizer-BioNTech COVID-19 vaccine SLE RA Immunosuppressive therapy Humoral immune response Cellular immune response booster mRNA COVID-19 vaccine Pfizer-BioNTech COVID-19 vaccine

Interventions

All patients will receive a booster Pfizer-BioNTech COVID-19 vaccine and be tested the immune response at day 15 after vaccination. If the anti-RBD Ig (Abbott Diagnostics, Abbott Park, Ill) is not rea
Experimental Biological/Vaccine
Booster

Sponsors

Ratchadapiseksompotch Fund, Faculty of Medicine
Lead Sponsor
Thai Rheumatism Association
Collaborator

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, who have been vaccinated with either inactivated SARS-CoV-2 or viral-vector ChAdOx1 nCoV-19 COVID-19 vaccine

Exclusion criteria

Exclusion criteria: Pregnancy, History of SARS-CoV-2 infection

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)—

Countries

Thailand

Contacts

Public ContactTheerada Assawasaksakul

Faculty of Medicine, Chulalongkorn University

theerada.azza@gmail.com0830730873

Outcome results

None listed

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