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)

Introduction Live attenuated vaccines (LAVs) are recommended during moderate corticosteroid therapy ( 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).