Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases
PCV20-PARD
Safety and Immunogenicity of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Children and Adolescents With Autoimmune Rheumatic Diseases
1 other identifier
interventional
114
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedStudy Start
First participant enrolled
January 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
March 4, 2026
November 1, 2025
12 months
August 20, 2025
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroconversion Rate After Vaccination
Will be defined as ≥2-fold increase in IgG titers for ≥50% of serotypes.
Day 0 to Day 28 and through 180 days
Secondary Outcomes (8)
Opsonophagocytic Antibody Titers (OPA)
Day 0 to Day 28 and through 180 days
Safety Assessment
Day 1 through Day 28
Impact of PCV20 vaccination on Disease Activity on patients with JIA
Day 1 through Day 28
Impact of PCV20 vaccination on Disease Activity on patients with JSLE
Day 1 through Day 28
Impact of PCV20 vaccination on Disease Activity on patients with JDM
Day 1 through Day 28
- +3 more secondary outcomes
Study Arms (2)
ARDs
EXPERIMENTALPCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.
Healthy control
ACTIVE COMPARATORPCV20 (Prevenar 20) vaccine administered intramuscularly in 1 dose depending on age and prior vaccination history.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 2-25 years
- Diagnosis of JIA, jSLE, or JDM by validated classification criteria
- Clinically stable
- Informed consent/assent
You may not qualify if:
- Acute infection or fever at vaccination
- Severe allergic reaction to vaccine components
- Recent blood transfusion (\<6 months)
- Pregnancy or breastfeeding
- Prior PCV20
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulo General Hospitallead
- Insituto Adolfo Lutzcollaborator
Study Sites (1)
Hospital das Clinics da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil
Related Publications (5)
Kobayashi M, Bennett NM, Gierke R, Almendares O, Moore MR, Whitney CG, Pilishvili T. Intervals Between PCV13 and PPSV23 Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2015 Sep 4;64(34):944-7. doi: 10.15585/mmwr.mm6434a4.
PMID: 26334788BACKGROUNDJensen L, Christensen AE, Nielsen S, Pedersen FK, Rosthoj S, Jorgensen CS, Poulsen A. Response to pneumococcal conjugate and polysaccharide vaccination in children with rheumatic disease. Scand J Immunol. 2022 Feb;95(2):e13118. doi: 10.1111/sji.13118. Epub 2021 Nov 22.
PMID: 34768311BACKGROUNDAikawa NE, Franca IL, Ribeiro AC, Sallum AM, Bonfa E, Silva CA. Short and long-term immunogenicity and safety following the 23-valent polysaccharide pneumococcal vaccine in juvenile idiopathic arthritis patients under conventional DMARDs with or without anti-TNF therapy. Vaccine. 2015 Jan 29;33(5):604-9. doi: 10.1016/j.vaccine.2014.12.030. Epub 2014 Dec 29.
PMID: 25554240BACKGROUNDAikawa NE, Campos LM, Goldenstein-Schainberg C, Saad CG, Ribeiro AC, Bueno C, Precioso AR, Timenetsky Mdo C, Silva CA, Bonfa E. Effective seroconversion and safety following the pandemic influenza vaccination (anti-H1N1) in patients with juvenile idiopathic arthritis. Scand J Rheumatol. 2013;42(1):34-40. doi: 10.3109/03009742.2012.709272. Epub 2012 Sep 20.
PMID: 22992045BACKGROUNDAikawa NE, Campos LM, Silva CA, Carvalho JF, Saad CG, Trudes G, Duarte A, Miraglia JL, Timenetsky Mdo C, Viana VS, Franca IL, Bonfa E, Pereira RM. Glucocorticoid: major factor for reduced immunogenicity of 2009 influenza A (H1N1) vaccine in patients with juvenile autoimmune rheumatic disease. J Rheumatol. 2012 Jan;39(1):167-73. doi: 10.3899/jrheum.110721. Epub 2011 Nov 15.
PMID: 22089462BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2025
First Posted
November 28, 2025
Study Start
January 16, 2026
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2027
Last Updated
March 4, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share