Respiratory syncytial virus (RSV) is a common cause of respiratory tract infections leading to hospitalizations in infants and in elderly. Arexvy is an approved vaccine for the prevention of RSV infection, however, data on its efficacy in individuals aged 80 years and older remain limited. This study aims to evaluate potential differences in immune responses to Arexvy vaccination between adults aged ≥80 years and those aged 60-65 years.
Respiratory syncytial virus (RSV) is a common cause of respiratory tract infections that frequently lead to hospitalization, particularly in infants and older adults. The virus relies on two surface glycoproteins, F and G, for cell fusion and attachment, respectively. Among these, the F protein is the primary target of neutralizing antibodies and a critical focus in RSV vaccine development. RSV spreads through contaminated nasal secretions via large droplets, primarily transmitted through close human contact or contaminated surfaces. Notably, RSV infection does not confer lasting immunity, and the disease imposes a significant burden on healthcare systems, especially among infants and older adults-particularly those over 75 or with underlying health conditions. Despite more than half a century of research and a considerable global need, progress in RSV vaccine development has been slow. A key challenge has been inducing antibody (Ab) responses that are sufficiently specific, broad, and long-lasting to provide effective protection. However, in recent years, major strides have been made: two RSV vaccines were approved in 2023, and one in 2024, in both Europe and the United States, for the prevention of lower respiratory tract disease (LRTD) in individuals aged 60 years and older, as well as adults 50-59 years old at increased risk for RSV. Arexvy, developed and manufactured by GSK, is an adjuvanted RSV vaccine based on the prefusion-stabilized F protein. Its formulation includes the AS01E adjuvant, selected based on prior clinical data. A single dose of Arexvy has demonstrated efficacy against LRTD across three RSV seasons in adults aged 60 and above. The vaccine has shown an acceptable safety and reactogenicity profile. Despite these advancements, there remains limited data on vaccine responses in individuals aged 80 and above, as well as in frail populations, due to their underrepresentation in ongoing clinical trials. While some immunogenicity data are available, a substantial knowledge gap persists regarding the immune responses elicited by Arexvy in this highly vulnerable group who are disproportionately affected by severe RSV infections. Therefore, studying possible differences in the immune response induced upon vaccination with Arexvy between elderly above 80 years of age and younger individuals (60 65 years old) will provide key insights for defining future vaccination strategies in these populations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
65
The RSV vaccine (Arexvy) has demonstrated efficacy against LRTD over three RSV seasons in individuals aged 60 and older, with an acceptable safety and reactogenicity profile. However, data on vaccine responses in individuals aged 80 and older, including frail individuals, remains limited. This population is particularly affected by severe RSV infections, highlighting the need for further investigation to address these gaps.
Familjeläkarna SÄBO
Saltsjöbaden, Sweden
RECRUITINGAkademiskt specialistcentrum Studieenheten
Stockholm, Sweden
RECRUITINGPrimary endpoint:
To assess the neutralizing antibody geometric mean titers (GMTs) against RSV A and B one month after the prime dose (day 31) of Arexvy in study participants aged 60-65 years and ≥80 years old, measured by a neutralization assay. Mean geometric increase (MGI), geometric increase (MGI) between day 0 and day 31 after prime will be calculated (equal to the geometric mean of the individual ratio). A more detailed description can be found in section 10.2.1.
Time frame: Day 31
Primary objective
To describe the induction of neutralizing antibodies against RSV A and B following the first dose of Arexvy in older adults aged 80 years and older and those aged 60 to 65 years.
Time frame: Day 31
Secondary objective:
To evaluate the reactogenicity of Arexvy by recording the occurrence of solicited adverse events (AEs) in the study participants.
Time frame: Between day 0 to 18 month
Secondary objectives
To evaluate the safety of Arexvy in terms of the incidence of unsolicited AEs, SAEs/pIMDs and fatal SAEs.
Time frame: Between day 0 to 18 month
Secondary endpoint
Incidence of SAEs, pIMDs, and fatal SAEs among study participants receiving Arexvy.
Time frame: Between day 0 - 18 month
Seconda y endpoint
Incidence of unsolicited AEs in the study participants with an onset during the 30 day follow-up period after each vaccination.
Time frame: Between day 0-day 30 after each vaccination
Secondary endpoint
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Incidence of SAEs or pIMDs in the study participants from the day of vaccination until 6 months.
Time frame: Between day 0-6 month after each vaccination
Secondary endpoint
Occurrence of any fatal SAEs from day 1 up to study end.
Time frame: Between day 0 to 18 month