Actively Recruiting
Immunogenicity After Prime Dose and Revaccination With Adjuvanted RSVPreF3 Vaccine in Elderly and Frail Adults - Open-label Phase IIIb Trial
Led by Karin Karin Loré · Updated on 2025-10-02
65
Participants Needed
2
Research Sites
104 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) commonly causes respiratory infections leading to hospitalizations, especially in infants and older adults. Arexvy is an approved vaccine aimed at preventing RSV infections, but there is limited data on its immune response in people aged 80 and older. This study aims to compare immune responses to Arexvy between adults aged 80 and above and those aged 60 to 65 to better understand vaccination effects in these age groups. Participants will receive an initial dose of the Arexvy vaccine followed by a booster dose one year later. The study includes two groups: adults aged 60 to 65 living in the community and adults aged 80 and above, including those in long-term care facilities. Vaccinations and follow-ups will be conducted at designated clinical centers and care facilities, with an open-label design and no placebo group. Throughout the study, participants will be monitored for immune responses primarily around day 31 after vaccination, with secondary assessments extending up to 18 months. The study will collect data on antibody responses, vaccine safety, and reactogenicity. Participants will have regular visits for evaluations, and the research will provide insights into the vaccine's effects in the oldest and frail populations over the study period.
CONDITIONS
Brief 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 born in 1945 or earlier, living in the community or long-term care.
- Able to read and understand Swedish.
- Able and willing to provide written informed consent.
- Medically stable at the time of first vaccination as judged by the investigator.
- May have chronic stable conditions like diabetes, hypertension, or cardiac disease if stable.
- Able and willing to comply with study protocol requirements.
You will not qualify if you...
- Medically immunocompromised individuals or those less than 2 years post stem cell transplant or with graft-versus-host disease.
- Solid-organ transplant recipients or those on immunosuppressive cancer treatments.
- Prior receipt of any RSV vaccine.
- Known allergies or hypersensitivity to vaccine components.
- Mental incapacity, reluctance, or language difficulties affecting consent.
- Medical conditions that may affect treatment or study results.
- Unstable chronic illness or uncontrolled neurological disorders.
- Significant illness preventing study completion or unsafe intramuscular injections.
- History of dementia or cognitive impairment affecting consent.
- History of chronic alcohol or drug abuse impairing study compliance.
- Participation in other clinical trials with RSV or hMPV vaccines.
- Planned relocation preventing study completion.
- Relation to study personnel or sponsor.
- Receipt of other vaccines less than 14 days before or after study vaccination; 30 days for Shingrix vaccine.
- Participation in other clinical trials during study period or previous RSV/hMPV prophylaxis trials.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year between prime dose and revaccination
Participants receive a prime vaccination with the Arexvy RSV vaccine, followed by a revaccination one year later to study immune responses.
2 vaccination visits and multiple follow-up visits up to 18 months
Duration - Up to 18 months
Participants are monitored for immune response and safety for up to 18 months after the first vaccination.
Periodic visits during the 18 months following vaccination
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
F
Florian Gegenfurtner, MSc
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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