Data results from its phase 3 trial showed it was statistically significant and the company plans to follow-up with regulatory bodies later this year.
Today, GSK reported its investigational respiratory syncytial virus (RSV) vaccine demonstrated it was “statistically significant and clinically meaningful efficacy in adults aged 60 years and above.”
This result comes from its AReSVi 006 phase 3 trial, which is a randomized, placebo-controlled, observer-blind, multi-country study to demonstrate the efficacy of a single dose of GSK's adjuvanted RSVPreF3 OA vaccine in individuals aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries.
GSK also reported that in-house results from a parallel phase 3 trial, AReSVi 004, using its 1 dose of their investigational RSV OA vaccine, which, “induced strong humoral and cellular immune responses, which remain above pre-vaccination levels up to at least the six months post-vaccination readout timepoint,” a company statement read.
“These data suggest our RSV vaccine candidate offers exceptional protection for older adults from the serious consequences of RSV infection,” Hal Barron, MD, Chief Scientific Officer and president, R&D, GSK. “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 hospitalizations and more than 24,000 deaths worldwide each year.”
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 is used with several of GSK’s established adjuvanted vaccines. The antigen plus adjuvant combination may help overcome the natural age-related decline in immunity that contributes to the challenge of protecting older adults from RSV disease.
The company is planning to follow-up with federal regulatory bodies later this year in pursuit of approvals.
“Given the importance of these data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022,” Barron stated.