New York- 12 August 2024- Pfizer announced positive top-line safety and immunogenicity results from sub-study B of the ongoing pivotal Phase 3 clinical trial MONeT, 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).
Adults with immunocompromising conditions have an increased risk of developing RSV-LRTD. Sub-study 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 sub-study, approximately half were between the ages of 18 to 59, and approximately half were 60 years or older.
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ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. While the company evaluated two doses, a single 120 µg dose of ABRYSVO generated a strong neutralizing response against both subtypes of RSV, RSV-A and RSV-B, across all cohorts and age groups in the study.
“We are encouraged by the positive top-line data from this study, which provide important evidence that ABRYSVO has the potential to address a significant unmet need in this vulnerable population.” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.
