Immunodeficiency
Conditions
Interventions
Group 1:One dose of PCV13 vaccine in the group of children with juvenile idiopathic arthritis (JIA)
Group 2:One dose of PCV13 vaccine in the paediatric group for haematopoietic stem cell transplantation (HSCT)
Group 3:Healthy children receive a single dose of the PCV13 vaccine.
Sponsors
Chinese Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
2 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1. Juvenile idiopathic arthritis (JIA) children group: (1) Diagnosed with JIA at the Department of Rheumatology and Immunology, Capital Children's Medical Centre (all subtypes are eligible); (2) Current age 2-5 years old (over 2 years old and under 6 years old); (3) No previous pneumococcal vaccination; (4) Guardian's consent for PCV13 vaccination; (5) The current stage of treatment is assessed to be amenable to PCV13: 1) At least 2 weeks before the next dose of anti-CD20 monoclonal antibody is administered and at least 6 months before the previous dose is administered; and 2) The equivalent dose of glucocorticosteroids is less than 20 mg/d and lasts for >=2 weeks; (6) Guardian's consent for blood specimen collection and follow-up. 2. Haematopoietic stem cell transplantation (HSCT) children group: (1) Children who have undergone HSCT in the Haematology Department of Capital Children's Medical Centre; (2) Current age 2-5 years old (over 2 years old and under 6 years old); (3) Guardian's consent to vaccinate them with PCV13; (4) The current stage of treatment is assessed to be suitable for PCV13 vaccination: 1) 3 months have elapsed since HSCT; 2) The basic condition is stable after transplantation; 3) The underlying disease has reached a complete remission or (in the case of lymphoma and multiple myeloma) the haematology is in good partial remission; (5) The guardian agrees to blood specimen collection and accepts follow-up. 3. Healthy control group: (1) Healthy and free of major diseases; (2) Aged 2-5 years (2 years old and less than 6 years old), in the same age group as the children in the PD high-risk group (accurate to +/- 6 months); (3) No previous pneumococcal vaccination; (4) Guardian's consent to be vaccinated with PCV13; (5) Guardian consent for blood specimen collection and follow-up.
Exclusion criteria
Exclusion criteria: 1. Juvenile idiopathic arthritis (JIA) children group: (1) Known hypersensitivity to any of the active ingredients, excipients or diphtheria toxoid/tetanus toxoid (severe) contained in PCV13; (2) Guardian does not consent to study participation. 2. Haematopoietic stem cell transplantation (HSCT) paediatric group: (1) Known hypersensitivity to any of the active ingredients contained in PCV13, excipients or diphtheria toxoid/tetanus toxoid (severe); (2) Received a donor lymphocyte infusion within 28 days or plasma products or immunoglobulins within 60 days prior to enrolment; (3) Received rituximab (within 6 months), relapsed chemotherapy for underlying malignancy; (4) Is in acute or chronic graft-versus-host disease; (5) Guardian does not consent to participate in the study. 3.Healthy control group: (1) Known hypersensitivity to any of the active ingredients, excipients or diphtheria toxoid/tetanus toxoid (severe) contained in PCV13; (2) Have used blood products or injected immunoglobulins within the last 60 days; (3) Guardian does not consent to participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of IgG antibodies to 13 serotypes of Pneumococcus pneumoniae;Adverse reactions (local reactions following vaccination, such as induration, redness, and swelling at the injection site; and systemic reactions, including fever, allergic reactions, vomiting, diarrhea, irritability, drowsiness, rash, cough, decreased appetite, and reduced activity level).; | — |
Countries
China
Contacts
Public ContactMa Chao
Chinese Center for Disease Control and Prevention
Outcome results
None listed