Immunosuppression and pediatric rheumatic disease Musculoskeletal Diseases
Conditions
Interventions
During the trial safety of the varicella zoster virus vaccine will be assessed by determining whether adverse effects have occurred, including flares of the pediatric rheumatic diseases by sending out
Sponsors
German Center for Pediatric and Adolescent Rheumatology
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Varicella zoster virus IgG level measured by commercial ELISA within 4 to 12 weeks after each vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety, assessed using a questionnaire of possible adverse effects at 12 weeks after vaccination 2. Long-term clinical efficacy, assessed using an interview regarding the occurrence of chickenpox or herpes zoster after 3 years | — |
Countries
Germany
Outcome results
None listed