Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality
Conditions
Interventions
Intervention1: MMR vaccine - Tresivac® (Serum Institute of India), Edmonston-Zagreb Measles virus CCID50 not 1,000, CCID50 L-Zagreb Mumps virus 5,000, and Winstar RA27/3 Rubella virus 1,000, CCID50
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age at screening more than 12 months 2. Currently on therapy with steroids for NS. 3. Proteinuria in remission with urine protein creatinine ratio less than 0.2 mg/mg 4 .Ongoing prednisolone therapy with less than 1.5 mg/kg (maximum 40 mg) alternate day dose. 5. Normal immune responsiveness satisfying both a) b) and c) at baseline a. Humoral immunity with IgG level more than 300 mg/dL b. Cellular immunity with CD4+ T cells more than 500/mm3, c. Cellular immunity functional assay - normal lymphocyte blast transformation by phytohemagglutinin (stimulation index more than 101.6) If any criteria is negative, repetition can be done after 1 week to reassess for enrolment (especially time to IgG recovery can be slower after relapse). If two assays performed 1 week apart show any defect in immune responses, patient will be re-rescreened after 4 weeks if in remission. 6. Negative seroprotective titers for any one of mumps, measles, rubella and varicella (MMR/V) (negative values below 11, 16.5,10 and 150 AU per ml for mumps, measles, rubella and varicella, respectively). 7. Written informed consent from parents/legally accepted representatives
Exclusion criteria
Exclusion criteria: 1.Suspected or proven sepsis currently or within 1 week of enrollment 2.Estimated glomerular filtration rate less than or equal to 90 ml/min per 1.73 m2 (as per modified Schwartz equation) 3.History of anaphylaxis/allergy to varicella or MMR vaccines, or its components 4.Currently on therapy with levamisole, mycophenolate mofetil, tacrolimus, rituximab (on or up to 6 months after last dose) or cyclophosphamide (on or up to 3 months after last dose) or steroids more than 1.5 mg/kg (maximum 40 mg) alternate day dose 5. Patients living more than 200 km from the center and unwilling for follow-up as planned 6.Leucopenia, neutropenia or lymphopenia (total WBC less than or equal to 4,000/mm3, absolute neutrophil and lymphocyte count less than or equal to 1,500/mm3) 7. Blood or blood products or immunoglobulin received in the last 12 months. 8. Secondary nephrotic syndrome (lupus, IgA nephropathy, membranous or membranoproliferative glomerulonephritis, etc.) 9. Children who had varicella, mumps, measles or rubella illness in the last 8 weeks (clinical or virological diagnosis) 10. Children who are currently in contact with a pregnant woman at their home
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of participants achieving seroconversion to either varicella or MMR vaccine or both, 4 weeks after administration, between two groups of children with nephrotic syndrome (administered during the last 2 weeks of alternate day corticosteroid therapy versus administered 4 weeks after discontinuation of steroids).Timepoint: 4 weeks after administration of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Mean geometric mean titers for antibodies against the 4 viruses will be compared across the two groupsTimepoint: 4 weeks after administration of intervention;Safety of LAV in NS, as measured by SAEsTimepoint: 1 year of followup | — |
Countries
India
Contacts
Public ContactDr Georgie Mathew
Christian Medical College, Vellore
Outcome results
None listed