Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases (PCV20-PARD)

March 2, 2026 updated by: University of Sao Paulo General Hospital

Safety and Immunogenicity of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Children and Adolescents With Autoimmune Rheumatic Diseases

This clinical trial evaluates the immunogenicity (humoral and cellular) and safety of the 20-valent pneumococcal conjugate vaccine (PCV20) in children, adolescents, and young adults aged 2-25 years with autoimmune rheumatic diseases (ARDs). All participants will receive PCV20 according to prior vaccine history. Antibody titers, opsonophagocytic activity, cellular immune responses, and adverse events will be measured up to 6 months post-vaccination. Effects of immunosuppressive therapy and physical activity levels related vaccine response will also be assessed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

ARD patients are at higher risk of pneumococcal infections due to disease-related and therapy-induced immunosuppression. Despite vaccination recommendations, immunogenicity data for PCV20 in ARD pediatric populations are lacking. This prospective phase IV study will enroll 85 patients aged 2-25 years diagnosed with juvenile idiopathic arthritis (JIA), juvenile systemic lupus erythematosus (jSLE), and juvenile dermatomyositis (JDM). All will receive PCV20 per CDC guidance. Blood samples will be collected at baseline (D0), 4 weeks (D28), and 6 months (D180). The functional opsonophagocytic activity (OPA) for specific serotypes will be analyzed. Safety will be monitored through adverse event diaries, clinical evaluations, and disease activity indices. Physical activity will be evaluated by validated questionnaires and via accelerometry.

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil
        • Recruiting
        • Hospital das Clinics da Faculdade de Medicina da Universidade de Sao Paulo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 2-25 years
  • Diagnosis of JIA, jSLE, or JDM by validated classification criteria
  • Clinically stable
  • Informed consent/assent

Exclusion Criteria:

  • Acute infection or fever at vaccination
  • Severe allergic reaction to vaccine components
  • Recent blood transfusion (<6 months)
  • Other vaccine within 4 weeks prior at the time of inclusion
  • Pregnancy or breastfeeding
  • Prior PCV20

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARDs
PCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.
Biological: Pneumococcal Vaccine
0.5 mL intramuscular dose containing polysaccharide conjugates for 20 pneumococcal serotypes (PCV20, Prevenar 20) vaccine will be administered intramuscularly in 1 dose in patients with ARDs and healthy controls.
Other Names:
  • 20-valent pneumococcal conjugate vaccine
Active Comparator: Healthy control
PCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.
Biological: Pneumococcal Vaccine
0.5 mL intramuscular dose containing polysaccharide conjugates for 20 pneumococcal serotypes (PCV20, Prevenar 20) vaccine will be administered intramuscularly in 1 dose in patients with ARDs and healthy controls.
Other Names:
  • 20-valent pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion Rate After Vaccination
Time Frame: Day 0 to Day 28 and through 180 days
Will be defined as ≥2-fold increase in IgG titers for ≥50% of serotypes.
Day 0 to Day 28 and through 180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opsonophagocytic Antibody Titers (OPA)
Time Frame: Day 0 to Day 28 and through 180 days
Blood samples will be collected at three time points: before the first dose (D0), 4 weeks after the first dose (D28), and six months after the final dose (D180). Functional opsonophagocytic anticapsular antibodies will be quantified using 6 validated serotype-specific opsonophagocytic activity (OPA) assays. Results will be expressed as geometric mean titers (GMTs) for each serotype and the percentage of participants reaching titers equal to or above the lower limit of quantification (LLOQ).
Day 0 to Day 28 and through 180 days
Safety Assessment
Time Frame: Day 1 through Day 28
Safety will be closely monitored, and all serious adverse events will be classified as related or unrelated to the vaccine. A standardized adverse event diary will be provided to all patients and healthy controls for recording local and systemic reactions during the 4 weeks after first dose. Local reactions include: injection site pain, redness, swelling, bruising, itching, and induration. Systemic reactions include: fever, fatigue, chills, malaise, drowsiness, loss of appetite, nausea, vomiting, diarrhea, abdominal pain, dizziness, tremors, headache, fatigue, myalgia, muscle weakness, arthralgia, pruritus, and skin rash.
Day 1 through Day 28
Impact of PCV20 vaccination on Disease Activity on patients with JIA
Time Frame: Day 1 through Day 28

To evaluate the impact of PCV20 vaccination on clinical disease activity in patients with JIA, measured using JADAS27, higher scores indicate greater disease activity.

Unit of Measure: Score (0-57)
Day 1 through Day 28
Impact of PCV20 vaccination on Disease Activity on patients with JSLE
Time Frame: Day 1 through Day 28

To evaluate the impact of PCV20 vaccination on clinical and laboratory disease activity in patients with juvenile systemic lupus erythematosus (jSLE), assessed using the SLEDAI-2K. The score incorporates clinical and laboratory manifestations of lupus, with higher scores indicating greater disease activity.

Unit of Measure: Score (range 0-105)
Day 1 through Day 28
Impact of PCV20 vaccination on Disease Activity on patients with JDM
Time Frame: Day 1 through Day 28

To evaluate the impact of PCV20 vaccination on clinical and laboratory disease activity in patients with juvenile dermatomyositis (JDM), assessed using the Childhood Myositis Assessment Scale (CMAS). The CMAS evaluates muscle function and endurance, with higher scores indicating better muscle strength and physical performance.

Unit of Measure: Score (range 0-52)
Day 1 through Day 28
Influence of Immunosuppressive Treatment
Time Frame: Day 0 to Day 180
To assess the short- and long-term influence of immunosuppressive treatment on the response to PCV-20 vaccination in patients with ARDs compared to healthy controls.
Day 0 to Day 180
Seroconversion Rates after PCV20 vaccination by Physical Activity Classification
Time Frame: Day 1 to 180 post-vaccination

Proportion of participants who achieve seroconversion defined as at least a twofold increase in pneumococcal serotype-specific IgG antibody concentrations compared to baseline at Days 28 and 180 following PCV20 vaccination.

Participants will be categorized as physically active or inactive based on World Health Organization criteria using validated methods.
Day 1 to 180 post-vaccination
Geometric Mean Titers of Pneumococcal Antibodies after PCV20 Vaccination by Physical Activity Classification
Time Frame: Day 1 to 180 post-vaccination

Geometric mean titers of pneumococcal serotype-specific IgG antibodies will be quantified using multiplex Luminex assay at Days 28 and 180 after PCV20 vaccination.

Participants will be classified as physically active or inactive according to the World Health Organization criteria, based on validated methods.
Day 1 to 180 post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Insituto Adolfo Lutz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

August 20, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75531023.0.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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