This is the first RSV vaccination candidate to show clinically meaningful and statistically significant efficacy in adults aged 60 years and older.
GSK announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 phase 3 trial, which exceeded its primary endpoint with no unexpected safety concerns observed.1
The interim analysis investigated GSK’s respiratory syncytial virus (RSV) vaccine candidate for individuals aged 60 years and older and was reviewed by an independent data monitoring committee.1
“These data suggest our RSV vaccine candidate offers exceptional protection for older adults from the serious consequences of RSV infection. 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,” Hal Barron, MD, chief scientific officer and president of research and development at GSK, said in a statement.
“Given the importance of these data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022,” he said.1
Results from the phase 3 trial will be presented in a peer-reviewed publication at an upcoming scientific meeting. Additionally, the AReSVi 006 trial will continue to evaluate both an annual revaccination schedule and longer-term protection over multiple seasons following 1 dose of the RSV older adult vaccine candidate.1
AReSVI 006 is a multi-country, observer-blind, placebo-controlled, randomized trial to demonstrate the efficacy of a single dose of GSK’s adjuvanted RSVPreF3 OA investigational vaccine in adults who are aged 60 years or older.1
Approximately 25,000 individuals were enrolled from 17 countries.1
The trial is also part of a comprehensive RSV evidence generation program conducted by GSK. Recent in-house results from a parallel phase 3 trial, investigating the immunogenicity, persistence, reactogenicity, and safety of the vaccine candidate, showed that, in individuals aged 60 years and older, 1 dose of the vaccine induced cellular immunity and string humoral responses, which remained above pre-vaccination levels up to at least 6 months post-vaccination readout timepoint.1
The RSV older adult vaccine candidate contains recombinant subunit prefusion RSV F glycoprotein antigen combines with the company’s proprietary AS01 adjuvant. 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.1
RSV leads to approximately 177,000 hospitalizations and 14,000 deaths among adults aged 65 years and older each year in the United States, according to the CDC.2
Additionally, RSV leads to 2.1 million outpatient visits and 58,000 hospitalizations among children who are younger than aged 5 years each year in the United States, according to the CDC.2
In the United States, RSV infections occur primary during the fall, winter, and spring, according to the CDC.
1. GSK announces positive pivotal phase III data for its respiratory syncytial virus (RSV) vaccine candidate for older adults. GSK. News release. June 10, 2022. Accessed June 10, 2022. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-pivotal-phase-iii-data-for-its-respiratory-syncytial-virus-rsv-vaccine-candidate-for-older-adults/
2. Respiratory syncytial virus infection. CDC. Updated December 18, 2020. Accessed June 10, 2022. https://www.cdc.gov/rsv/research/us-surveillance.html