Older Adult Vaccine Candidate Shows Significant Reduction in Severe RSV

GSK plc today announced very positive clinical trial results for its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above.

RSV is a common contagious virus affecting the lungs and breathing passages without a U.S. FDA-approved vaccine.

GSK's adjuvanted RSVPreF3 OA investigational vaccine was found highly efficacious in the pivotal AReSVi-006 phase III trial, demonstrating overall vaccine efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs. 40 of 12,494) against RSV lower respiratory tract disease (RSV-LRTD), meeting the trial's primary endpoint.

Consistent high vaccine efficacy was also observed across a range of pre-specified secondary endpoints, highlighting the impact the vaccine candidate could have on the populations most at risk of the severe outcomes of RSV.

Efficacy against severe RSV-LRTD, defined as LRTD with at least two lower respiratory signs or assessed as severe by the investigator and confirmed by the external adjudication committee, was 94.1% (95% CI, 62.4–99.9, 1 of 12,466 vs. 17 of 12,494).

And in participants with pre-existing comorbidities, such as underlying cardiorespiratory and endocrinometabolic conditions, vaccine efficacy was 94.6% (95% CI, 65.9–99.9, 1 of 4,937 vs. 18 of 4,861), with 93.8% (95% CI, 60.2-99.9, 1 of 4,487 vs. 16 of 4,487) efficacy observed in adults aged 70-79 years.

Vaccine efficacy against LRTD was consistent across both RSV-A and RSV-B subtypes (84.6%; CI 32.1–98.3, 2 of 12,466 vs. 13 of 12,494 and 80.9%; CI 49.4–94.3, 5 of 12,466 vs. 26 of 12,494 respectively), consistent with the robust neutralizing antibody response generated against both subtypes.

Tony Wood, GSK Chief Scientific Officer, said in a press release on October 13, 2022, "These are truly exceptional results given that today RSV remains one of the major infectious diseases without a vaccine, despite over 60 years of research."

"We believe that with the high vaccine efficacy demonstrated in this pivotal trial, our vaccine candidate has the potential to help reduce the significant global burden of RSV-associated disease in older adults, including those at the greatest risk of severe outcomes due to their age or underlying comorbidities."

Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate chronic obstructive pulmonary disease, asthma, heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.

RSV causes over 420,000 hospitalizations yearly and 29,000 deaths in adults in industrialized countries.

In addition, adults with underlying conditions are more likely to seek medical advice and have higher hospitalization rates than adults without these conditions.

There are several RSV vaccine candidates approaching approval that are listed on this webpage.

This GSK announcement was manually curated for mobile readers and is not paid content.