COVID-19 booster vaccine in autoimmune disease non-responders (ACV01)

ACV01 was a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring immunosuppressive (IS) medications. All study participants had negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine. The adult stages of the study focused on adult participants with at least 1 of 5 autoimmune diseases: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), multiple sclerosis (MS), systemic sclerosis (SSc), and pemphigus. The pediatric stages of the study focused on pediatric participants with 1 of 4 autoimmune diseases: pediatric SLE, juvenile idiopathic arthritis (JIA), juvenile dermatomyositis (JDM), or pediatric-onset multiple sclerosis (POMS). Participants were assigned to cohorts based on their IS regimens: receipt of mycophenolate mofetil (MMF) or mycophenolic acid (MPA; Cohorts A and D), receipt of methotrexate (MTX; Cohorts B and E); and receipt of any B-cell depletion therapy (BCDT) within the past 18 months (Cohorts C and F). For each age group, Stage 1 participants received an additional dose of the same COVID-19 vaccine as their original vaccine series, and Stage 2 participants received a dose of an alternative COVID-19 vaccine compared to their previous COVID-19 vaccine doses.