MedTrace Logo

Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs

NCT07242092 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-03-24

No results posted yet for this study

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?

Conditions

  • Autoimmune Rheumatic Diseases

Interventions

BIOLOGICAL

Pneumococcal Vaccine

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.

Sponsors & Collaborators

  • Insituto Adolfo Lutz

    collaborator UNKNOWN

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2027-12-30
Completion
2028-12-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07242092 on ClinicalTrials.gov