GSK has released positive topline data from a Phase 3 trial that assessed the coadministration of Arexvy (respiratory syncytial virus [RSV] vaccine, adjuvanted) and Shingrix (zoster vaccine recombinant, adjuvanted).
The trial involved adults aged 50 years and older to assess the immunogenicity, reactogenicity and safety of Arexvy when co-administered with Shingrix.
Shingrix is approved for preventing shingles in adults aged 50 and older.
On the other hand, Arexvy is approved for preventing lower respiratory tract disease caused by RSV in individuals 60 and older, as well as those aged 50-59 at increased risk.
The co-administration study is a Phase 3, open-label, multi-country trial that randomised 530 participants in a 1:1 ratio.
It assessed the non-inferiority of immune responses when GSK’s RSV vaccine is co-administered with the Recombinant Zoster Vaccine (RZV) in adults aged 50 and older.
One group received the RZV first dose and the RSV vaccine at the first visit, while the control group received the RZV alone at the first visit and the RSV vaccine 31 days later.
The RZV second dose was administered to both groups on day 61.
The primary endpoint focused on the non-inferiority of humoral immune responses to both vaccines when co-administered versus sequentially administered.
Results showed that anti-gE antibody concentrations and RSV neutralisation titers increased significantly post-vaccination, meeting the primary endpoint of non-inferiority.
The duration of solicited adverse events was short and comparable between groups.
Co-administration was well tolerated, with acceptable reactogenicity and safety profiles.
In addition, rates of unsolicited adverse events were balanced between the co-administration and control groups.
GSK scientific affairs and public health vice president Len Friedland said: “Adult immunisation offers immense individual and societal benefits and yet, vaccination rates for adults are often inadequate.
“With our co-administration studies, GSK is using its science and technology to help remove barriers to adult immunisation, by potentially reducing the number of visits to the healthcare offices and pharmacies and ultimately help to get ahead of RSV and shingles.”
Results from this trial will support regulatory submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory bodies.
Last month, the European Commission approved Arexvy for active immunisation to prevent lower respiratory tract disease (LRTD) caused by RSV in adults aged 50-59 who are at higher risk.
