GSK Reports Positive Results for AREXVY and SHINGRIX Co-Administration

PHILADELPHIA, PA, USA I September 18, 2024 I GSK plc (LSE/NYSE: GSK) has announced promising results from a phase 3 clinical trial involving adults aged 50 and above, assessing the immunogenicity, reactogenicity, and safety of co-administering AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) with SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted). These findings were presented at the European Geriatric Medicine Society Congress in Valencia, Spain.

SHINGRIX is an approved vaccine for preventing shingles (herpes zoster) in individuals 50 years and older. AREXVY is approved for preventing lower respiratory tract disease (LRTD) caused by the respiratory syncytial virus (RSV) in adults aged 60 and older, and in those 50 to 59 years old who are at increased risk for RSV-related LRTD.

The trial results demonstrated that the immune response was non-inferior when both vaccines were administered together compared to separate administrations. Additionally, co-administration was well tolerated with acceptable reactogenicity and safety profiles. Common adverse events included pain at the injection site, fatigue, and muscle pain, with a comparable duration of these events between both groups.

Len Friedland, MD, Vice President of Scientific Affairs and Public Health at GSK, expressed enthusiasm about the findings, emphasizing the potential of co-administration to enhance adult immunization rates by reducing the number of healthcare visits required for vaccination against RSV and shingles.

The results from this trial are intended for submission to peer-reviewed journals and regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to support further regulatory submissions.

Both RSV and shingles present substantial health risks to older adults, which increase with age due to the decline of the immune system. Individuals with compromised immune systems or underlying conditions like asthma or chronic obstructive pulmonary disease (COPD) are also at heightened risk for these diseases. RSV, a highly contagious respiratory virus, can lead to severe illness and even death among older adults. Annually, approximately 177,000 adults aged 65 and older are hospitalized in the US due to RSV, with around 14,000 fatalities. Shingles is another significant concern, characterized by a painful, blistering rash that can result in long-term nerve pain known as post-herpetic neuralgia (PHN).

AREXVY comprises recombinant RSV glycoprotein F stabilized in the prefusion conformation, combined with GSK’s proprietary AS01E adjuvant. This vaccine has received approval for preventing RSV-LRTD in individuals aged 60 and above in 50 countries, including Europe, Japan, and the US. It is also approved in several countries for adults aged 50 to 59 at increased risk for RSV-LRTD, with ongoing regulatory reviews in multiple countries.

SHINGRIX, a non-live, recombinant subunit vaccine, is designed to prevent shingles in adults aged 50 and above. It incorporates glycoprotein E with the AS01B adjuvant system to address the age-related decline in immune response that makes older adults more susceptible to shingles. The vaccine is also approved for adults aged 18 and over who are at increased risk for shingles in several countries.

The NCT05966090 trial was a phase 3, open-label, multi-country study aimed at evaluating the non-inferiority of immune responses when co-administering GSK's RSV and Recombinant Zoster Vaccine (RZV) compared to separate administrations in adults aged 50 and above. The study involved 530 participants and assessed the primary endpoint of non-inferiority in humoral immune responses, with key secondary endpoints evaluating reactogenicity and safety. Results indicated that both the immune response and safety profiles met the non-inferiority criteria, with similar adverse event durations and rates between the co-administration and control groups.

RSV is a common respiratory virus that poses significant risks to older adults, especially those with pre-existing health conditions. Shingles, caused by the reactivation of the varicella-zoster virus, typically presents with painful blisters and can lead to long-term nerve pain.

GSK is committed to leveraging its scientific and technological expertise to advance adult immunization and reduce the burden of diseases like RSV and shingles.