Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs
Effect of Methotrexate Discontinuation on Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Patients With Autoimmune Rheumatic Diseases
University of Sao Paulo General Hospital
192 participants
Jun 22, 2026
INTERVENTIONAL
Conditions
Summary
This clinical trial aims to evaluate the effect of temporary methotrexate (MTX) discontinuation on the humoral immunogenicity of the 20-valent pneumococcal conjugate vaccine (PCV20) in adult patients with autoimmune rheumatic diseases (ARDs). Key questions: * Does suspending MTX for 2 weeks after PCV20 enhance humoral immunogenicity? * What is the impact of MTX discontinuation on functional opsonophagocytic activity (OPA) and cellular immunity? * What is the risk of disease flaring with MTX withdrawal?
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
All participants will receive a single intramuscular dose (0.5 mL) of PCV20 (Prevnar 20®, Pfizer), administered into the deltoid muscle at baseline (Day 0). PCV20 contains purified capsular polysaccharides of 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F), individually conjugated to the nontoxic diphtheria CRM197 carrier protein. The conjugation induces a T-cell dependent immune response, resulting in higher-affinity antibodies and immune memory compared to polysaccharide vaccines.
Locations(1)
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NCT07242092