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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат 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.

Первичные конечные точки

• Seroconversion Rate After Vaccination [Срок оценки: Day 0 to Day 28 and through 180 days]

Вторичные конечные точки (8)

• Opsonophagocytic Antibody Titers (OPA) [Срок оценки: Day 0 to Day 28 and through 180 days]
• Safety Assessment [Срок оценки: Day 1 through Day 28]
• Impact of PCV20 vaccination on Disease Activity on patients with JIA [Срок оценки: Day 1 through Day 28]
• Impact of PCV20 vaccination on Disease Activity on patients with JSLE [Срок оценки: Day 1 through Day 28]
• Impact of PCV20 vaccination on Disease Activity on patients with JDM [Срок оценки: Day 1 through Day 28]
• Influence of Immunosuppressive Treatment [Срок оценки: Day 0 to Day 180]
• Seroconversion Rates after PCV20 vaccination by Physical Activity Classification [Срок оценки: Day 1 to 180 post-vaccination]
• Geometric Mean Titers of Pneumococcal Antibodies after PCV20 Vaccination by Physical Activity Classification [Срок оценки: Day 1 to 180 post-vaccination]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Бразилия · 1 центр

• Hospital das Clinics da Faculdade de Medicina da Universidade de Sao Paulo — São Paulo

Публикации

• 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 26334788
• Jensen 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 34768311
• Aikawa 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 25554240
• Aikawa 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 22992045
• Aikawa 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 22089462

Идентификаторы

NCT: NCT07252791 · 75531023.0.0000.0068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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