論文: CPT: Pharmacometrics & Systems Pharmacology
要約
This study applied a Model-Based Meta-Analysis (MBMA) across seven placebo-controlled clinical trials of respiratory syncytial virus (RSV) vaccines in older adults to quantify how immunogenicity relates to clinical protection. Results showed that serum neutralizing activity (SNA) correlates strongly with vaccine efficacy across multiple disease severities, supporting its use as a surrogate marker and immune correlate of protection. Cell-mediated immunity (CMI) may also contribute to protection against more severe RSV disease. These findings support immunobridging strategies to accelerate RSV vaccine development and strengthen regulatory interactions under emerging guidance such as ICH M15.
Author(s): Yushi Kashihara | Li Qin | Shinji Shimizu | Paul Matthias Diderichsen | Masakatsu Kotsuma | Kazutaka Yoshihara
Year: 2025年10月6日
Respiratory Syncytial Virus (RSV), Vaccinology / Infectious diseases, Respiratory disease
Power next-generation immunology strategies with model-based meta-analysis (MBMA)
Using Model-Based Meta-Analysis, Certara connects immune response markers to clinical outcomes, enabling more efficient study design, faster development timelines, and more confident regulatory decision-making for vaccines and immunotherapies.
