Phase 3 trial results indicate efficacy against respiratory syncytial virus-lower respiratory tract disease in individuals aged 60 years and older.
A vaccine candidate from GSK met the primary endpoint of vaccine efficacy against respiratory syncytial virus (RSV)-lower respiratory tract disease in adults aged 60 years and older.
The New England Journal of Medicine published the positive phase 3 trial results, which included pivotal efficacy data that were previously presented at IDWeek 2022.
“Our ambition is to protect the many older adults at risk from RSV disease, including those with underlying health conditions, who account for the majority of severe RSV outcomes,” Tony Wood, chief scientific officer at GSK, said in a statement. “We look forward to making the vaccine available as quickly as possible, pending regulatory decisions, and sharing more data from our ongoing clinical development program as we work to get ahead of this potentially debilitating virus.”
Additionally, GSK will be conducting 3 additional phase 3 trials, aiming to expand the population who may benefit from the RSV vaccination to individuals aged 50 to 59 years with underlying comorbidities and to provide further evidence on co-administration with other older adult vaccines. The data will also build upon additional data from the AReSVi-006 (NCT04886596) phase 3 efficacy trial and the AReSVi-004 (NCT04732871) immunogenicity trial.
NCT05590403 will evaluate the immunogenicity and safety of the vaccine candidate in adults aged 50 to 59 years, including those at risk of RSV-lower respiratory tract disease compared with its immunogenicity and safety in adults aged 60 years and older.
NCT05568797 and NCT05559476 will evaluate the vaccine candidate’s immunogenicity, reactogenicity, and safety when co-administered with adjuvanted and high-dose influenza vaccines in adults aged 65 years and older.
These trials build upon positive data on the concomitant administration of the RSV vaccine candidate with seasonal quadrivalent influenza vaccination. The trial results are expected in 2023.
“Although RSV often results in mild symptoms, it can have devastating consequences for older adults and has a global burden that can approach that of seasonal influenza,” Martinón-Torres, coordinator of the vaccine clinical trials unit at Instituto de Investigación Sanitaria de Santiago, Spain, said in the statement. “The publication of these important data shows that, for the first time, we are on the cusp of having an effective vaccine that could meaningfully impact public health.”
GSK is on track to supply the vaccine candidate ahead of the 2023 to 2024 northern hemisphere RSV season, pending regulatory decisions in the European Union, Japan, the United States, and other countries, the company announced in a press release. The FDA’s Vaccines and Related Biological Products Advisory Committee will review the biologics license application on March 1, 2023.
There are no RSV vaccines currently approved anywhere in the world.
Landmark New England Journal of Medicine publication reinforces potential of GSK’s respiratory syncytial virus older adult vaccine candidate. GSK. News release. February 15, 2023. Accessed February 22, 2023. gsk.com/en-gb/media/press-releases/nejm-publication-reinforces-potential-of-gsk-s-respiratory-syncytial-virus-older-adult-vaccine-candidate/