RSV Immunogenicity Study in the Elderly (RISE)

NCT07203365 | Recruiting Phase 3

• 2 other identifiers: RISE2024-520141-23-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

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

RSV Immunisation

Keywords

RISE; RSV vaccination; Respiratory syncytial virus; Elderly; Arexvy

Outcome Measures

Primary Outcomes (2)

• Primary 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.

  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.

  Day 31

Secondary Outcomes (6)

• Secondary objective:

  Between day 0 to 18 month

• Secondary objectives

  Between day 0 to 18 month

• Secondary endpoint

  Between day 0 - 18 month

• Seconda y endpoint

  Between day 0-day 30 after each vaccination

• Secondary endpoint

  Between day 0-6 month after each vaccination

Study Arms (2)

Individuals of the age of 60 to 65 years old.

ACTIVE COMPARATOR

Participants will receive a prime vaccination with Arexvy (RSV vaccine), followed by a revaccination after one year. These participants will be enrolled at the Clinical Trial Unit at the Academic Specialist Center, Region Stockholm.

Biological: This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65

Individuals ≥80 years old.

EXPERIMENTAL

Participants will receive a prime vaccination with Arexvy (RSV vaccine) and revaccination after one year. Participants in the older age group (80 years and above) will be enrolled at long-term care facilities at Familjeläkarnas Särskilda boenden (SÄBO).

Biological: This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65

Interventions

This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65 BIOLOGICAL

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.

Individuals of the age of 60 to 65 years old.; Individuals ≥80 years old.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female individuals who were born between 1965 and 1960 or 1945 and before, at the time of the first vaccination, who live in the community or in a long-term care facility.
• Individuals who can understand and read Swedish.
• Individuals who can provide written consent and agree (by written consent) to receive the Arexvy vaccine.
• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Participants who are medically stable in the opinion of the investigator at the time of first vaccination.
• Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate if considered by the investigator as medically stable.

You may not qualify if:

• Individuals who are medically immunocompromised, less than 2 years since hematopoietic stem cell transplantation (HSCT) or graft-versus-host disease (GVHD), solid-organ transplanted, using immunosuppressive drugs for treatment of cancer and who have inflammatory mediated or autoimmune conditions, as judged by the Investigator.
• Individuals who have already received an RSV vaccine dose at any time in the past.
• Any known or suspected reaction, hypersensitivity or allergies to be exacerbated by any product or component included in the vaccine and trial.
• Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial.
• Treatment or disease which, according to the investigator, can affect treatment or trial results.
• Any of the following medical conditions: Unstable chronic illness, Recurrent or un-controlled neurological disorders or seizures, Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study, Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe, Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study, Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures, History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
• Participation in another clinical trial during the study period, or any previous clinical trials with RSV- or hMPV-vaccine or other prophylaxis.
• Planned move during the study period that will prohibit participating in the study until study end.
• Participation of any study personnel or their immediate dependents, family or household members as well as any family relations to Sponsor or PI.
• Co-administration of other vaccines less than 14 days before or after study vaccination. A period of less than 30 days before or after study vaccination applies in the case of Shingrix.

Sponsors & Collaborators

• Karin Karin Loré: lead
• Karolinska Institutet: collaborator

Study Sites (2)

Familjeläkarna SÄBO

Saltsjöbaden, 13334, Sweden

RECRUITING

Akademiskt specialistcentrum Studieenheten

Stockholm, 113 61, Sweden

RECRUITING

Study Officials

• Helena Hervius Askling, Dr

  Studieenheten Akademiskt Specialistcentrum

  PRINCIPAL INVESTIGATOR

• Christian Molnár, Dr

  Familjeläkarnas Särskilda boenden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Loré, Professor

CONTACT

+46852480000; karin.lore@ki.se

Florian Gegenfurtner, MSc

CONTACT

+46852480000; florian.gegenfurtner@ki.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable; both arms receive active treatment with the Arexvy vaccine, administered according to the assigned regimen.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Parallel assignment to evaluate the induction of neutralizing antibodies against RSV A and RSV B following the first dose of Arexvy in two age groups: older adults aged ≥80 years and adults aged 60-65 years.

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: October 2, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2029
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)