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June 13, 2022

GSK reports positive Phase III data for RSV vaccine in elderly

In the trial, the primary endpoint was exceeded without any unexpected safety concerns reported.

GlaxoSmithKline (GSK) has reported positive headline data from a pre-specified efficacy interim assessment of the AReSVi 006 Phase III clinical trial of respiratory syncytial virus (RSV) vaccine candidate in adults aged 60 years and older.

The RSV older adult (OA) vaccine candidate has a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3), along with the company’s AS01 adjuvant.

This antigen plus adjuvant combination could potentially aid in overcoming the natural age-associated decline in immunity that causes the challenge of protecting older individuals from RSV infection.

The randomised, placebo-controlled, observer-blind, multi-country trial analysed the efficacy of one dose of the investigational adjuvanted RSVPreF3 OA vaccine in adults aged 60 years and above. 

Nearly 25,000 subjects were enrolled from 17 countries in the trial.

The Independent Data Monitoring Committee analysed the interim assessment data and noted that the primary endpoint was exceeded without any unexpected safety concerns reported. 

The magnitude of effect reported was similar across RSV A and B strains, the crucial secondary endpoints, and in people aged 70 years and over.

Furthermore, the AReSVi 006 trial will continue to assess an annual revaccination schedule, as well as longer-term protection over various seasons by administering a single dose of the RSV OV vaccine candidate.

GSK R&D chief scientific officer and president Dr Hal Barron 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.”

With the latest development, the company plans to make regulatory submissions in the second half of this year.

In July last year, the company reported positive headline data from five trials of the Phase III ASCEND programme of daprodustat for anaemia in chronic kidney disease (CKD) patients.

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