Arexvy Shows Non-Inferior Immune Response Against Lower Respiratory Tract Disease From RSV

Adjuvanted respiratory syncytial virus (RSV) vaccine (Arexvy; GlaxoSmithKline plc) demonstrated non-inferior immune responses in adults aged 50 to 59 years compared to adults aged 60 and older at risk for RSV lower respiratory tract disease (LRTD), according to the preliminary findings from a phase 3 trial (NCT05590403). Currently the vaccine is approved in the United States for the active immunization for the prevention of RSV-LRTD in adults aged 60 years and older.

Image credit: MargJohnsonVA | stock.adobe.com

The vaccine includes a recombinant glycoprotein F stabilized in the prefusion conformation, according to a statement. The results of the study were presented at the CDC Advisory Committee on Immunization Practices meeting on October 25, 2023.

“This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD. We will submit these data for regulatory review as quickly as possible with the goal of offering adults in this age group the option of a vaccine for the first time,” Tony Wood, PhD, chief scientific officer at GSK, said in the statement.

The placebo-controlled, observer-blind, randomized study aimed to evaluate the non-inferiority of the immune response of Arexvy in the 50 to 59 years of age range who have an increased risk of RSV-LRTD compared to those aged 60 years and above. Investigators evaluated a single dose of the RSV vaccine. The study assessed the immune responses of 570 individuals aged 50 to 59 years with pre-defined stable chronic diseases that increased the risk of RSV disease. The diseases included chronic pulmonary disease, chronic cardiovascular disease, diabetes, chronic kidney disease, or chronic liver disease.

Furthermore, investigators also evaluated the immune response of 570 individuals aged 50 to 59 without any pre-defined chronic diseases compared to those aged 60 and older. There were a total of 1520 individuals enrolled in the study from 8 countries.

The study met its co-primary endpoints of eliciting an immune response for this age range compared to those aged 60 years and older who have an increased risk of disease due to underlying medical conditions and the broader group of adults aged 50 to 59 years, according to the statement.

Furthermore, the safety and reactogenicity data were consistent with the results in the initial phase 3 program, according to the statement. The most common local adverse event (AE) was pain, with the most common systematic AEs including fatigue and headache, which were reported to be mild in intensity and transient.

The final results of the study will be presented at an upcoming medical conference and submitted for peer-reviewed publication, as well as the FDA and other regulators for a potential label expansion.

The vaccine was approved by the FDA in May 2023 for the prevention of LRTD caused by RSV in those aged 60 years and older, followed by the authorization of the vaccine by the European Commission in June 2023 and Japan’s Ministry of Health, Labour, and Welfare in September 2023. Further, the vaccine has also been approved in the United Kingdom and Canada, with review by regulatory agencies ongoing in other countries, according to the statement.

Reference

New data for Arexvy, GSK’s RSV vaccine, show potential to help protect adults aged 50 to 59 at increased risk for RSV disease. News release. GSK. October 25, 2023. Accessed October 26, 2023. https://www.gsk.com/en-gb/media/press-releases/new-data-for-arexvy-show-potential-to-help-protect-adults-aged-50-to-59/