GSK, formerly GlaxoSmithKline, (GSK ) has today announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial investigating GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above.
The multinational pharmaceutical company says its RSV vaccine candidate is the first to show statistically significant and clinically meaningful efficacy in adults aged 60 years and above.
The phase III trial is a placebo-controlled, observer-blind, multi-country trial to demonstrate the efficacy of a single dose of GSK’s adjuvanted RSVPreF3 OA investigational vaccine in adults aged 60 years and above. Around 25,000 participants were enrolled from 17 countries.
The interim analysis was reviewed by an Independent Data Monitoring Committee, and the primary endpoint of the trial was exceeded with no unexpected safety concerns observed.
The trial will continue to evaluate both an annual revaccination schedule and longer-term protection over multiple seasons following one dose of the RSV older adult (OA) vaccine.
The Company’s RSV OA vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01 adjuvant. AS01 has already been used with several of the company’s established adjuvanted vaccines.
The antigen plus adjuvant combination could also help overcome the natural age-related decline in immunity that contributes to the challenge of protecting older adults from RSV.
RSV, a contagious virus affecting the lungs and breathing passages, is one of the major remaining infectious diseases for which there is currently no vaccine or specific treatment. Each year, RSV causes over 360,000 hospitalisations and 24,000 deaths globally in adults.
Dr Hal Barron, CSO and President, R&D, GSK, stated: “RSV remains one of the few major infectious diseases without a vaccine, and these data have the potential to meaningfully impact the treatment of RSV and may reduce the 360,000 hospitalisations and more than 24,000 deaths worldwide each year. Given the importance of this data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022.”
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