Safety and immunogenicity of live attenuated vaccines during corticosteroid therapy in children with nephrotic syndrome: protocol for an open-label, non-inferiority, randomised controlled trial (VACCINES trial: VAccines in Children on CorticosteroIds for NEphrotic Syndrome)
Abstract
Introduction: Live attenuated vaccines (LAVs) are recommended during moderate corticosteroid therapy (<2 mg/kg per day) for nephrotic syndrome (NS) largely based on observational/case-control study data. We aim to conduct a randomised controlled trial (RCT) to assess the safety and immunogenicity of LAVs in children with NS.
Methods and analysis: To test the safety and immunogenicity of LAVs in NS in children on moderate dose corticosteroid therapy (1.5 mg/kg alternate day dose with maximum 40 mg alternate day dose; early arm) vs those off corticosteroid therapy for 4 weeks (standard arm), we are conducting a single-centre, open-label, non-inferiority RCT at a tertiary care centre in South India (VACCINES trial: Vaccines in Children on Corticosteroids for NEphrotic Syndrome). Eligible children (after inclusion and exclusion criteria) will be enrolled after obtaining written informed consent (from a legally accepted representative/parents) as well as assent for children aged >12 years. Two doses of measles, mumps, rubella (MMR) and/or varicella vaccines will be administered 12 weeks apart, after the initial assessment of seroprotection. Immunological assessment of humoral and cellular immunity will be evaluated in eligible participants. Randomisation into the standard and early arms will be performed during the last 2 weeks of alternate-day therapy (stratified into first episode and relapse patients). Seroconversion assessments will be made at 4, 12, 16 and 52 weeks into the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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