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CDC-9 Inactivated Rotavirus Vaccine (IRV) is a novel vaccine candidate currently in clinical development. Unlike the currently licensed live oral rotavirus vaccines, CDC-9 IRV is an inactivated vaccine administered intramuscularly (IM). The vaccine is derived from a human G1P[8] rotavirus strain and is currently undergoing Phase 1 clinical trials in healthy adults aged 18-45 years. The trial is evaluating two dose levels (3.75 μg and 7.5 μg) given as a 3-dose series to assess safety and immune response. Preclinical studies in gnotobiotic piglets showed protection against oral rotavirus challenge. Research has identified a human monoclonal antibody binding to a region of VP4 that neutralizes human rotavirus, suggesting a potential mechanism involving blocking virus penetration. Studies in rodent models indicate that co-administration with inactivated polio vaccine (IPV) does not reduce CDC-9 immunogenicity, unlike potential interference seen with live oral vaccines. The development of CDC-9 IRV aims to address limitations of live oral rotavirus vaccines, such as potential intussusception risk and immune interference.
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