Ison, M.G., et al. Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): a multicentre, randomised, observer-blinded, placebo-controlled, phase 3 trial.

Ison, M.G., et al. Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): a multicentre, randomised, observer-blinded, placebo-controlled, phase 3 trial.

Lancet Respir Med, 2025 Apr 11, S2213-2600(25)00048-7. PMID: 40245915 

• This study evaluates the efficacy, safety, and immunogenicity of the AS01E-adjuvanted RSV prefusion F protein vaccine in older adults over three RSV seasons. The research focuses on how well the vaccine protects against RSV-related lower respiratory tract disease, particularly in individuals aged 60 and older. 

• The exposed population included 24,972 participants: 12,469 received RSVPreF3 OA and 12,503 received placebo before RSV season one. The cumulative efficacy of a single RSVPreF3 OA dose in preventing RSV-LRTD over three RSV seasons was 62.9% (97.5% CI 46.7–74.8). Between dose one and trial end, eight (<1%) participants in the RSV single-dose group, 12 (<1%) in the RSV revaccination group, and 12 (<1%) in the placebo group had a serious adverse event. 

• Comment: While the paper discusses that the AS01E adjuvant is used with the RSVPreF3 OA vaccine to enhance the immune response to the RSV fusion (F) protein, the paper does not provide definitive evidence linking the adjuvant directly to the level of efficacy observed. 

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