China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced receiving clinical approval from the US Food and Drug Administration (FDA) for its SCB-1019, a non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate. The company has initiated the first subjects for the Phase I revaccination study, assessing the safety, reactogenicity, and immunogenicity of the vaccine.
Clinical Trial Details
The ongoing trial in the US is enrolling up to 160 older adults (60-85 years) who previously received an initial dose of GSK’s RSV vaccine (AREXVY) at least two seasons prior. Participants will be randomized to receive either a heterologous revaccination dose of SCB-1019, based on Clover’s Trimer-Tag vaccine technology platform, a homologous AREXVY revaccination dose, or a saline placebo.-Fineline Info & Tech
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