Vaccination against chickenpox in immunosuppressed children with rheumatic diseases

Completed

• Conditions: Immunosuppression and pediatric rheumatic disease; Musculoskeletal Diseases

• Registration Number: ISRCTN21654693
• Lead Sponsor: German Center for Pediatric and Adolescent Rheumatology

Brief Summary

1. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29499726 (added 22/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-05-31
• Study Start: 2018-02-12
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Negative medical history for chickenpox and herpes zoster, corroborated by negative VZV-IgG level
2. Not more than 1 prior dose of the VZV vaccine
3. Diagnosis of an inflammatory pediatric rheumatic disease
4. Clinical inactive pediatric rheumatic disease
5. No change of IS for at least 3 months prior to the vaccination

Exclusion Criteria

1. Acute febrile disease
2. Current clinical or laboratory evidence for lack of immunologic reactivity
3. Known hypersensitivity to constituents of the varicella vaccine
4. Measles, mumps, rubella (MMR) vaccination within 4 weeks prior to VZV vaccination
5. Treatment with immunosuppressive therapy other than those mentioned in the pre-vaccination checklist, i.e. i.v. glucocorticoid pulse therapy or a prednisone-equivalent dose of more than 2mg/kg/day or more than 20mg/day for > 2 weeks within less than 4 weeks prior to vaccination, cyclophosphamide pulse <6 months ago, rituximab without B-cell reconstitution, intravenous immune globulins (IVIG) <6 months ago (high-dose IVIG (2g/kg) <11 months), therapy with aspirin until 6 week post-vaccination or any blood products <3 months prior to vaccination

Study & Design

• Study Type: Observational
• Study Design: Not specified