The pursuit for an effective vaccine against the respiratory syncytial virus (RSV) may be at an inflection point. GlaxoSmithKline disclosed positive headline data Friday from a pre-specified efficacy interim analysis of the Phase III trial of its RSV vaccine.
The study was designed to test the efficacy of a single dose of the vaccine in adults 60 years and older. There were about 25,000 participants in 17 countries. The study was part of GSK’s comprehensive RSV evidence generation program. In a parallel trial, AReSVi 004, the vaccine induced strong humoral and cellular immune responses. That immunity remained above pre-vaccination levels up to at least six months after the post-vaccination readout.
The RSV OA vaccine comprises a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with the company’s proprietary AS01 adjuvant. AS01 is utilized with several of the company’s other vaccines on the market. It contains Agenus’ proprietary QS-21 STIMULON within the AS01 adjuvant. The AS01 adjuvant is used in GSK’s Shingrix shingles vaccine and malaria vaccine, Mosquirix.
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