GSK plc has announced positive headline results from its AReSVi 006 phase III trial.
AReSVi 006 is a phase III trial investigating GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above.
GSK said no unexpected safety concerns were observed.
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 hospitalizations 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.”
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 vaccine candidate.
GSK’s RSV older adult vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s AS01 adjuvant. AS01 is used with several of GSK’s established adjuvanted vaccines.
The company dsaid 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.
About AReSVi 006
The AReSVi 006 phase III trial is a randomized, placebo-controlled, observer-blind, multi-country trial to demonstrate the efficacy of a single dose of GSK’s adjuvanted RSVPreF3 older adult investigational vaccine in adults aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries.
AReSVi 006 is part of an RSV evidence generation program conducted by GSK. Recent in-house results from a parallel phase III trial, AReSVi 004, investigating the immunogenicity, safety, reactogenicity, and persistence of the vaccine candidate in older adults showed that, in participants aged 60 years and above, one dose of the RSV vaccine induced strong humoral and cellular immune responses, which remain above pre-vaccination levels up to at least the six months post-vaccination readout timepoint.
About respiratory syncytial virus
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, asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.
RSV is also the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children younger than 1 year of age in the U.S.
Each year, RSV causes more than 360,000 hospitalizations and 24,000 deaths globally in adults. Adults with underlying conditions are more likely to seek medical advice and have higher hospitalization rates than adults without these conditions.
Last month, U.S. company Blue Lake Biotechnology, Inc. received U.S. Food and Drug Administration Fast Track designation for its RSV intranasal vaccine.
Cover image: GSK