Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
Last week, we reported on preliminary findings from a randomized, placebo-controlled study aimed to evaluate the non-inferiority of the immune response to the adjuvanted respiratory syncytial virus (RSV) vaccine Arexvy (GSK) in adults aged 50-59 years who have an increased risk of RSV-LRTD compared to those aged 60 years and above after a single dose of Arexvy. The results of the study were presented at the CDC Advisory Committee on Immunization Practices meeting on October 25, 2023.
The study assessed the immune responses of 570 individuals aged 50-59 years with predefined stable chronic diseases that increased the risk of RSV-LRTD including chronic pulmonary disease, chronic cardiovascular disease, diabetes, chronic kidney disease, or chronic liver disease. Researchers also evaluated immune response among 570 participants aged 50 to 59 years without underlying medical conditions. Immune response in both groups was compared to the response observed in adults aged 60 years and older. There were approximately 1520 participants enrolled from 8 countries.
The study met its co-primary endpoints of eliciting immune responses among the cohort aged 50 to 59 years at high risk for RSV LRTD as well as for the same-aged group not at increased risk that was noninferior to that observed in those aged 60 years and older.
In addition to the phase 3 study’s primary endpoints, RSV-A and RSV-B neutralization titers of both groups of 50- to 59-year-olds at 1-month post-vaccination compared to adults aged 60 and older, there were also safety and immunogenicity secondary and tertiary endpoints.
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