A co-administration option for both vaccinations can increase the likelihood of older adults completing the vaccination series and improve health outcomes for the patient population.
GSK reported positive topline data from a phase 3 study in adults 50 years and older assessing the immunogenicity, reactogenicity, and safety of its respiratory syncytial virus (RSV) vaccine (Arexvy) when co-administered with its recombinant zoster vaccine for shingles (Shingrix), in a news release.1 The data were presented as a late-breaking abstract at the European Geriatric Medicine Society Congress taking place September 18 to 20 in Valencia, Spain.
GSK signage / Eagle - stock.adobe.com
GSK’s RSV vaccine is FDA-approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older and individuals 50 through 59 years of age who are at increased risk for lower respiratory tract disease caused by RSV. The company’s shingles vaccine is FDA-approved for the prevention of shingles in adults 50 years and older and adults 18 years and older who are or will be at increased risk of shingles due to being immunocompromised by known disease or therapy.
About RSV-OA=ADJ-020
Trial Name: A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults (RSV-OA=ADJ-020)
Clinicaltrials.gov Identifier: NCT05966090
Sponsor: GlaxoSmithKline
Summary: To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged >=50 years of age.
“We are excited to share data on the co-administration of our RSV and shingles vaccine. Adult immunization offers immense individual and societal benefits and yet, vaccination rates for adults are often inadequate,” said Len Friedland, MD, vice president of scientific affairs and public health at GSK, in the same release.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 health care offices and pharmacies and ultimately help to get ahead of RSV and shingles.”
READ MORE: Community Pharmacist Education to Combat Vaccine Hesitancy
The phase 3, open-label, multi-country study (NCT05966090) enrolled 530 adults aged 50 years and over to compare the immune responses of vaccine co-administration to separate administration. Participants were randomly assigned 1:1 to receive both vaccines together in a single visit or to receive RSV alone followed by a second RSV dose 31 days later. Both groups received the second shingles dose 61 days after initial vaccination.
The primary endpoint was non-inferiority of the humoral immune responses to the RSV and shingles vaccines when co-administered compared to separate administration. Key secondary endpoints included reactogenicity and safety following co-administration compared to separate administration.
Anti-gE antibody concentrations and RSV-A and RSV-B neutralization titers increased from pre- to post-vaccination and met the non-inferiority criteria for the primary endpoint for humoral immune responses.2 Both groups experienced short-term, comparable adverse events, with the most common being pain at the injection site, fatigue, and myalgia. Reporting rates of unsolicited adverse events were similar between the co-administration and control groups.
GSK announced that results from its study will be submitted for publication in a peer-reviewed, scientific journal, and will be used to support regulatory submissions to the FDA, European Medicines Agency, and other regulators.1
Given their increased vulnerability to RSV and shingles due to aging and immune system decline, older adults should prioritize vaccination for the conditions. A co-administration option for both vaccinations can increase the likelihood of older adults completing the vaccination series and improve health outcomes for the patient population.
RSV, a common and contagious respiratory virus, can lead to potentially serious illness. Annually in the US, approximately 177,000 adults aged 65 and older are hospitalized due to RSV-related complications, and an estimated 14,000 of these cases result in death.3
Shingles, a painful, blistering rash that can last for weeks, is caused by the reactivation of the varicella-zoster virus, the same virus responsible for chickenpox. Although around 99% of US adults carry the virus, not everyone will develop shingles. Still, an estimated 1 million people in the US experience the condition annually.4
READ MORE: Immunization Resource Center
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