The first respiratory syncytial virus (RSV) vaccine candidate has shown statistically significant and clinically meaningful efficacy in adults aged 60 years and above.
The magnitude of effect observed was consistent across RSV A and B strains, key secondary endpoints and in those aged 70 years and above.
RSV is a common contagious virus affecting the lungs and breathing passages. It is one of the major remaining infectious diseases for which there is currently no vaccine or specific treatment.
Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate conditions including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.
Each year, RSV causes over 360,000 hospitalisations and 24,000 deaths globally in adults. Adults with underlying conditions are more likely to seek medical advice and have higher hospitalisation rates than adults without these conditions.
The positive headline results are from a pre-specified efficacy interim analysis of the AReSVi 006 phase III trial. The interim analysis was reviewed by an Independent Data Monitoring Committee, and the primary endpoint was exceeded with no unexpected safety concerns observed.
AReSVi 006 is a phase III trial investigating GlaxoSmithKline's (GSK) respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above.
One of the few major infectious diseases without a vaccine
Results from this phase III trial will be presented in a peer-reviewed publication and at an upcoming scientific meeting. The AReSVi 006 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 candidate.
Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: “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 hospitalisations and more than 24,000 deaths worldwide each year.
"Given the importance of these data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022.”
GSK’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.