Positive results were announced from a phase 3 trial evaluating the efficacy and safety of a single dose of RSVPreF3, a respiratory syncytial virus (RSV) vaccine candidate, for the prevention of lower respiratory tract disease caused by RSV in adults 60 years of age and older.
The vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with a proprietary adjuvant. The randomized, placebo-controlled, observer-blind AReSVi 006 trial (ClinicalTrials.gov Identifier: NCT04886596) includes approximately 25,000 adults 60 years of age and older who received a single dose of RSVpreF3.
The primary endpoint was the number of participants with first episode of reverse transcriptase-polymerase chain reaction (RT-PCR) confirmed RSV A and/or B associated with lower respiratory tract disease during the first seasons following a single dose of RSVPreF3.
According to an interim analysis, the study met its primary endpoint; the magnitude of effect was observed to be consistent across RSV A and B strains and in patients 70 years of age and older. Additionally, no unexpected safety concerns were reported. Full trial data will be presented in a peer-reviewed publication and at an upcoming scientific meeting.
Commenting on the results, Dr Hal Barron, CSO and President, R&D, GlaxoSmithKline said: “These data suggest our RSV vaccine candidate offers exceptional protection for older adults from the serious consequences of RSV infection. […] Given the importance of these data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022.”
GSK announces positive pivotal phase III data for its respiratory syncytial virus (RSV) vaccine candidate for older adults. News release. GlaxoSmithKline. Accessed June 10, 2022. https://us.gsk.com/en-us/media/press-releases/gsk-announces-positive-pivotal-phase-iii-data-for-its-respiratory-syncytial-virus-rsv-vaccine-candidate-for-older-adults/