Health Condition 1: N04- Nephrotic syndrome
Conditions
Interventions
Intervention1: MMR vaccine and Varicella vaccine: MMR vaccine - Tresivac (Serum Institute of India), Edmonston-Zagreb Measles virus CCID50 not 1,000, CCID50 L-Zagreb Mumps virus 5,000, and Winstar RA
Sponsors
Christian Medical College Vellore
Eligibility
Inclusion criteria
Inclusion criteria: Age at screening greater than or equal to 1 year Frequently or infrequently relapsing nephrotic syndrome; with or without steroid toxicity Currently on therapy with levamisole for nephrotic syndrome Proteinuria documented to be in remission with urine protein creatinine ratio lesser than or equal to 0.2 mg per mg Completed recent therapy with prednisolone more than or equal to 4 weeks prior Normal immune responsiveness satisfying both a) b) and c) at baseline a. Humoral immunity with IgG level greater than or equal to 300 mg per dL b. Cellular immunity CD4+ T cells greater than or equal to 500 per mm3, c.Cellular immunity functional assay - normal lymphocyte blast transformation by phytohemagglutinin (stimulation index greater than or equal to 50 percent) If any criteria is found to be 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 Negative seroprotective titers for any one of mumps, measles, rubella and varicella (cutoff IgG titres by enzyme immunoassay) Written informed consent from parents or legally accepted representatives
Exclusion criteria
Exclusion criteria: Suspected or proven sepsis currently or within 1 week of enrollment Estimated glomerular filtration rate less than or equal to 90 ml/min per 1.73 m2 (as per modified Schwartz equation)History of anaphylaxis/allergy to varicella or MMR vaccines, or its components Currently on therapy with mycophenolate mofetil, tacrolimus, rituximab (on or up to 6 months after last dose) or cyclophosphamide (on or up to 3 months after last dose) Patients living greater than 200 km from the center and unwilling for follow-up as planned Leucopenia, neutropenia or lymphopenia (total WBC less than or equal to 4,000 per mm3, absolute neutrophil and lymphocyte count less than or equal to 1,500 per mm3) Blood or blood products or immunoglobulin received in the last 12 months. Secondary nephrotic syndrome (lupus, IgA nephropathy, membranous or membranoproliferative glomerulonephritis, etc.) Children who had varicella, mumps, measles or rubella illness in the last 8 weeks (clinical or virological diagnosis) Children who are currently in contact with a pregnant woman at their home
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the composite seroconversion rates of any one or more of varicella and MMR vaccine, 4 weeks after administration of second dose, between two groups of children with nephrotic syndrome on levamisole therapy.Timepoint: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean geometric mean titers for antibodies against the 4 viruses will be compared with that of healthy controls. Timepoint: 4, 16 and 52 weeks;Safety of LAV in NS, as measured by SAEs Timepoint: 52 weeks | — |
Countries
India
Contacts
Public ContactGeorgie Mathew
Christian Medical College Vellore
Outcome results
None listed