What is Arexvy studying for RSV immunisation?

Arexvy is being studied to understand how it triggers immune responses in adults aged 80 and older compared to those aged 60 to 65. Researchers aim to learn how well the vaccine works in the oldest and frail individuals who are more vulnerable to severe RSV infections. This study is led by Karin Karin Loré and focuses on improving vaccination strategies for older adults.

Who may be eligible for this RSV immunisation clinical trial?

Adults aged 60 years or older who live in the community or long-term care facilities may be eligible, regardless of gender. Participants must be able to read and understand Swedish, provide written consent, and be medically stable. People who have already received an RSV vaccine or have certain medical conditions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this RSV immunisation clinical trial?

Study-related care, including the vaccine and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect support for all study procedures without charge.

Actively Recruiting

Phase 3

Age: 60Years +

All Genders

Healthy Volunteers

ID07203365

Study of Immune Responses to Arexvy RSV Vaccine in Adults Aged 60-65 Compared to Those 80 and Older

Led by Karin Karin Loré · Updated on 2025-10-02

Participants Needed

Research Sites

104 weeks

Total Duration

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 vaccines effects in the oldest and frail populations over the study period.

CONDITIONS

Brief Title

RSV Immunogenicity Study in the Elderly (RISE)

Who Can Participate

Age: 60Years +

All Genders

Healthy Volunteers

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.

Research Team

Karin Loré, Professor

Florian Gegenfurtner, MSc

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Study of Immune Responses to Arexvy RSV Vaccine in Adults Aged 60-65 Compared to Those 80 and Older

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria