August 15, 2024- Pfizer Inc. announced positive top-line safety and immunogenicity results from substudy B of the ongoing pivotal Phase 3 clinical trial ( NCT05842967 ) MONeT (RSV I Mmunizati ONStudy for Adul Ts at Higher Risk of Severe Illness), evaluating two doses of ABRYSVO vaccine in immunocompromised adults aged 18 and older at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine.
Adults with immunocompromising conditions have an increased risk of developing RSV-LRTD. Substudy B of the MONeT trial was conducted to assess the safety and immunogenicity of two doses of ABRYSVO, administered one month apart, in four groups of immunocompromised adults: those with non-small cell lung cancer, those on hemodialysis due to end-stage renal disease, those with autoimmune inflammatory disorder receiving active immunomodulator therapy, and solid organ transplant recipients. Of the 203 adults enrolled in the substudy, approximately half were between the ages of 18 to 59, and approximately half were 60 years or older.