Actively Recruiting
RSV Immunogenicity Study in the Elderly (RISE)
Led by Karin Karin Loré · Updated on 2025-10-02
65
Participants Needed
2
Research Sites
196 weeks
Total Duration
On this page
Sponsors
K
Karin Karin Loré
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RSV Immunogenicity Study in the Elderly (RISE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female individuals born between 1960 and 1965 or in 1945 or earlier, living in the community or long-term care facility
- Ability to understand and read Swedish
- Ability to provide written consent and agree to receive the Arexvy vaccine
- Investigator's opinion that participant can comply with study requirements
- Medically stable at time of first vaccination as judged by investigator
- Stable chronic medical conditions allowed if considered medically stable by investigator, such as diabetes, hypertension, or cardiac disease
You will not qualify if you...
- Medically immunocompromised individuals, less than 2 years since hematopoietic stem cell transplantation (HSCT) or graft-versus-host disease (GVHD), solid-organ transplant recipients, or using immunosuppressive drugs for cancer or inflammatory/autoimmune conditions
- Prior receipt of any RSV vaccine dose
- Known or suspected allergy or hypersensitivity to vaccine components
- Mental inability, reluctance, or language difficulties preventing understanding of trial participation
- Treatments or diseases that may affect trial results as judged by investigator
- Unstable chronic illness, recurrent or uncontrolled neurological disorders or seizures
- Significant underlying illness preventing study completion
- Conditions making intramuscular injection unsafe
- Medical conditions posing additional risk due to study participation
- History of dementia or conditions impairing cognition and consent understanding
- History of chronic alcohol or drug abuse affecting compliance or safety reporting
- Participation in other clinical trials during study period or prior RSV/hMPV vaccine or prophylaxis trials
- Planned move preventing study participation until end
- Study personnel or immediate family members' participation
- Co-administration of other vaccines less than 14 days before or after study vaccination; less than 30 days for Shingrix vaccine
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Familjeläkarna SÄBO
Saltsjöbaden, Sweden, 13334
Actively Recruiting
2
Akademiskt specialistcentrum Studieenheten
Stockholm, Sweden, 113 61
Actively Recruiting
Research Team
K
Karin Loré, Professor
CONTACT
F
Florian Gegenfurtner, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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