Search reports, ask a question, or jump to a page.
The problem
Intervention: Administration of MMR and/or varicella live attenuated vaccines during moderate-dose corticosteroid therapy (1.5 mg/kg alternate day dose)
Who it was tested with: Children with nephrotic syndrome, stratified by first episode or relapse; comparison group of 50 healthy children.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"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 study." The trial uses a randomised controlled design with predetermined non-inferiority margins and planned interim analysis to rigorously test whether current guidelines permitting LAVs during corticosteroid therapy are supported by evidence.
This is a protocol only, so efficacy and safety data are not yet available. The trial is single-centre and open-label, which may introduce bias. Results will not be available until after 2028.
Across countries and designs
1 study · 1 country
