GSK has announced positive results from a phase 3 trial of its respiratory syncytial virus (RSV) vaccine candidate, RSVPreF3 OA, for adults aged 60 years and above.
There is currently no US approved vaccine for RSV, a contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can be dangerous, especially for infants and older adults, according to the Centers for Disease Control and Prevention.
In the US alone, it is estimated that RSV infections in older adults account for 177,000 hospitalisations and 14,000 deaths each year.
The phase 3 AReSVi-006 trial showed the vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease (RSV-LRTD), meeting its primary endpoint.
Consistent high vaccine efficacy was also observed across a range of pre-specified secondary endpoints, underlining 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%. In participants with pre-existing comorbidities, such as underlying cardiorespiratory and endocrine metabolic conditions, vaccine efficacy was 94.6%, with 93.8% efficacy observed in adults aged 70 to 79 years.
The vaccine was well tolerated with a favourable safety profile, the company reported, and the observed solicited adverse events were typically mild-to-moderate, the most frequent being injection site pain, fatigue, myalgia and headache.
Commenting on the positive results, Tony Wood, GSK chief scientific officer, said: “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.”
The company anticipates to complete regulatory submissions based on the phase 3 data in the second half of 2022.