Patients under treatment of immunosuppressants (CsA, FK, MZR, NNF, AZP)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Equal or more than one years old. 2. Patients under treatment of immunosuppressants (CsA, FK, MZR, MMF, AZP, MTX) 3. Negative or borderline antibody titer of one or more of the following viruses: measles, rubella, varicella, or mumps. 4. Patients who cannot discontinue immunosuppressants because of primary disease. 5. Inactive primary disease. 6. Normal cellular immunity (CD4 counts>500/mm3, PHA lymphocyte stimulatory test-stimulation index>101.6). 7. Serum IgG level>300mg/dl 8. FK trough level<10ng/ml or CsA trough level<100ng/ml. 9. Approved by the committee for attenuated live vaccination in children receiving immunosuppressants.
Exclusion criteria
Exclusion criteria: 1. Steroid use of more than 1mg/kg/d. 2. For renal transplant recipients, <1 year since transplantation or acute rejection within the previous 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Analysis of antibody acquisition after vaccination classified by each virus. 2) Analysis of maintenance of acquired immunity classified by each virus especially after 1 year. 3) Analysis of incididence of adverse events classified by each virus. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Analysis of causes of vaccine failure. 2) Analysis of causes of adverse events. 3) Analysis of effect for prevention of virus infection. | — |
Countries
Japan
Contacts
National Center for Child Health and Development Nephrology and Rheumatology