PCV20 pneumococcal vaccine for children and young adults with autoimmune rheumatic diseases
Official title: Safety and Immunogenicity of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Children and Adolescents With Autoimmune Rheumatic Diseases
Run by University of Sao Paulo General Hospital · NCT07252791 · Data updated 2026-11-12
This study will test if the 20‑valent pneumococcal vaccine (PCV20) is safe and triggers antibody and cellular immune responses in people aged 2–25 with autoimmune rheumatic diseases.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 25 Years |
| Sex | All |
| Enrollment | 114 (estimated) |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | January 16, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT07252791 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are clinically stable patients aged 2–25 years with a confirmed diagnosis of JIA, jSLE, or JDM who have not previously received PCV20 and can provide consent/assent.
✕Probably not a fit
Patients with current fever or acute infection, a history of severe allergy to vaccine components, recent blood transfusion within 6 months, recent other vaccination within 4 weeks, prior PCV20, or those who are pregnant or breastfeeding would be ineligible and may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase IV, prospective study will enroll 85 patients aged 2–25 years with juvenile idiopathic arthritis, juvenile systemic lupus erythematosus, or juvenile dermatomyositis who are clinically stable. All participants will receive PCV20 according to prior vaccine history and CDC guidance, with blood samples collected at baseline, 4 weeks, and 6 months. Laboratory testing will measure serotype-specific antibody titers, opsonophagocytic activity, and cellular immune responses, while safety will be followed with adverse event diaries and disease activity indices. The study will also examine how ongoing immunosuppressive therapies and physical activity (by questionnaire and accelerometry) relate to vaccine responses.
Why it matters
Potential benefit: If successful, the results could show that PCV20 safely produces protective antibody and cellular responses in young people with autoimmune rheumatic diseases, supporting clearer vaccination guidance and better protection against pneumococcal infection.
How similar studies have gone: PCV20 has demonstrated immunogenicity in adults and in healthy pediatric populations, but published data are limited for children and young adults with autoimmune rheumatic diseases.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hospital das Clinics da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Clovis A Silva, Full Professor
- Email: reumatologia.fmusp@hc.fm.usp.br
- Phone: (11) 2661-6105
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.