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Phase 3 Study Displays Positive Results of Co-Administration of RSV and Shingles Vaccine
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Results displayed a non-inferior immune response of the co-administered vaccines, compared to administration in individual visits.
GSK announced positive data from a phase 3 trial that assessed the immunogenicity, reactogenicity, and safety of Arexvy (GSK), a respiratory syncytial virus (RSV) vaccine when co-administrated with Shingrix (Recombinant Zoster Vaccine, RZV; GSK), a shingles virus vaccine—both being adjuvant vaccines.1
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“We are excited to share data on the co‑administration of our RSV and shingles vaccines. Adult immunization offers immense individual and societal benefits and yet, vaccination rates for adults are often inadequate,” Len Friedland, MD, vice president of Scientific Affairs and Public Health at GSK, said in a news release.1
The common respiratory virus is known to impact the lungs and breathing passages, putting adults at increased risk for RSV due to preexisting medical conditions, immune compromised status, and those that are older aged. Similarly, shingles occurs in adults by age 50, caused by the reactivation of the varicella-zoster virus (VZV). Shingles presents as a rash, accompanied by painful blisters on the chest, abdomen, or face.2 Both RSV and shingles could result in significant health risks among older adults, targeting those that have underlying health conditions.3
The RSV vaccine, Arexvy includes recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3), combined with the ASO1E adjuvant. The vaccine received FDA approval in May 2023 for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older.4 Arexvy is also indicated for individuals aged 50 through 59 years and age that are at an increased risk for RSV LRTD.1
The shingles vaccine, RZV, combines an antigen, glycoprotein E, with an adjuvant system, AS01 that is indicated for the prevention of shingles among adults 50 years and older. The FDA approved RZV in October 2017, indicated for the prevention of shingles in adults 50 years and older and adults 18 years and older that are at an increased risk of shingles due to immunocompromised status.1
Aimed to provide a more convenient vaccination regimen, researchers conducted a phase 3, open-label, multi-country study that assessed non-inferiority of immune responses in co-administered RSV and shingles vaccine compared with separate administration among adults 50 years and older.1
The study authors noted that the trial included 530 individuals that were randomly assigned to receive an adjuvant first dose of RZV and Arexvy at visit 1, or a first dose of RZV alone at visit 1 (control). Following, the control group received Arexvy at day 31 and the second dose of RZV was given at day 61 in both randomized groups.1
The results displayed a non-inferior immune response of the co-administered vaccines compared with when they were administered in individual visits—meeting the primary end point. Additionally, the co-administered vaccines demonstrated well tolerability with adequate reactogenicity and safety profiles, according to study authors.1
In both groups, the most common adverse events included pain at injection site, fatigue, and myalgia.1
“With our co-administration studies, GSK is using its science and technology to help remove barriers to adult immunization, by potentially reducing the number of visits to the healthcare offices and pharmacies and ultimately help to get ahead of RSV and shingles,” said Friedland in a news release.1
REFERENCES
1. GSK Announces Positive Topline Data on Co-Administration of AREXVY and SHINGRIX. GSK. News release. September 18, 2024. Accessed September 19, 2024. https://www.businesswire.com/news/home/20240917307121/en/GSK-Announces-Positive-Topline-Data-on-Co-Administration-of-AREXVY-and-SHINGRIX
2. GSK Builds Combo Case for RSV, Shingles Shots With Phase III Data. BioSpace. September 19, 2024. Accessed September 19, 2024. https://www.biospace.com/press-releases/gsk-announces-positive-topline-data-on-co-administration-of-arexvy-and-shingrix
3. GSK touts co-administration data for RSV, shingles vaccines as narrowed CDC guidance threatens sales. Fierce Pharma. News release. September 18, 2024. Accessed September 19, 2024. https://www.fiercepharma.com/pharma/narrowed-rsv-cdc-guidelines-threaten-vaccine-sales-gsk-touts-co-administration-data-older
4. Pharmacy Times. FDA Approves First Respiratory Syncytial Virus Vaccine for Adults Aged 60 Years and Older. News release. May 3, 2023. Accessed September 19, 2024. https://www.pharmacytimes.com/view/fda-approves-first-respiratory-syncytial-virus-vaccine-for-adults-aged-60-years-and-older.
