Contagion C3671023 Substudy A (NCT05842967)(MONeT Study) is a phase 3, randomized, double-blind, placebo-controlled trial assessing the safety and immunogenicity of Pfizer’s RSVpreF vaccine in high-risk adults aged 18-59 with chronic medical conditions, such as pulmonary, cardiovascular, hepatic, renal, and metabolic disorders, including diabetes mellitus.
The study aims to show that the immune response in this younger high-risk group is non-inferior to that of adults aged 60 and older, as established in the pivotal phase 3 C3671013 study that demonstrated the vaccine’s efficacy against RSV Lower Respiratory Tract Illness (LRTI).
At IDWeek 2024, Elliot DeHaan, MD, director in vaccines clinical research and development at Pfizer, Inc, and lead clinician on this study, highlighted the significant findings, “What we found in this trial was that in adults 18 to 59 years of age with comorbid conditions such as chronic pulmonary conditions such as asthma, COPD, cardiovascular disease, and diabetes, these individuals had similar immune responses to adults 60 and older who were enrolled in the Renoir trial in which we demonstrated efficacy of that vaccine. This technique is called immuno-bridging, and what we can confer from that immuno-bridging result is that we expect the immune response to be the same in these individuals.”