Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autoimmune Rheumatologic Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ARDs

PCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.

Group Type EXPERIMENTAL

Pneumococcal Vaccine

Intervention Type BIOLOGICAL

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.

Healthy control

PCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.

Group Type ACTIVE_COMPARATOR

Pneumococcal Vaccine

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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20-valent pneumococcal conjugate vaccine

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes