RSV ImmunisationPhase 3RISENCT07203365
RSV Immunogenicity Study in the Elderly (RISE)
A Phase 3 study testing This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65 in people with RSV Immunisation, run by Karin Karin Loré at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- RSV Immunisation
- What is being tested?
- This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesSweden
- Study dates
- 25 Aug 2025to 31 May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Familjeläkarna SÄBO
Saltsjöbaden, 13334
Akademiskt specialistcentrum Studieenheten
Stockholm, 113 61
About this study
Official title: Immunogenicity After a Prime Dose and Revaccination With Adjuvanted RSVPreF3 Vaccine in the Most Elderly and Frail Population - an Open-labeled Phase IIIb-trial
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.
Read the detailed description
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.
- Conditions
- RSV Immunisation
- Being tested
- This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65
- Keywords
- RISE, RSV vaccination, Respiratory syncytial virus, Elderly, Arexvy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Biological: This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 31
Secondary outcomes (6)
Secondary objective:
To evaluate the reactogenicity of Arexvy by recording the occurrence of solicited adverse events (AEs) in the study participants.
Measured: 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.
Measured: Between day 0 to 18 month
Secondary endpoint
Incidence of SAEs, pIMDs, and fatal SAEs among study participants receiving Arexvy.
Measured: 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.
Measured: Between day 0-day 30 after each vaccination
Secondary endpoint
Incidence of SAEs or pIMDs in the study participants from the day of vaccination until 6 months.
Measured: Between day 0-6 month after each vaccination
Secondary endpoint
Occurrence of any fatal SAEs from day 1 up to study end.
Measured: Between day 0 to 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start25 Aug 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV ImmunisationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karin Karin Loré
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor-investigator, Karin Karin Loré, Karolinska Institutet
- Investigators
- Helena Hervius Askling, Dr, Principal investigator, Studieenheten Akademiskt SpecialistcentrumChristian Molnár, Dr, Principal investigator, Familjeläkarnas Särskilda boenden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203365
- Sponsor's protocol ID
- RISE
- Other IDs
- 2024-520141-23-01
- Acronym
- RISE
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. However, aggregate study results will be published and reported in accordance with applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity After a Prime Dose and Revaccination With Adjuvanted RSVPreF3 Vaccine in the Most Elderly and Frail Population - an Open-labeled Phase IIIb-trial
- ClinicalTrials.gov ID
- NCT07203365
- Acronym / sponsor ID
- RISE / RISE
- Conditions
- RSV Immunisation
- Keywords
- RISE, RSV vaccination, Respiratory syncytial virus, Elderly, Arexvy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Karin Karin LoréUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individuals of the age of 60 to 65 years old. | Active comparator | Biological: This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65Participants 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. |
| Individuals ≥80 years old. | Experimental | Biological: This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65Participants 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65The 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. | Biological | Individuals of the age of 60 to 65 years old., Individuals ≥80 years old. |
Primary outcome
Primary endpoint:
Time frame: Day 31
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.
Primary objective
Time frame: Day 31
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.
6 secondary outcomes
Secondary objective:
Time frame: Between day 0 to 18 month
Secondary objectives
Time frame: Between day 0 to 18 month
Secondary endpoint
Time frame: Between day 0 - 18 month
Seconda y endpoint
Time frame: Between day 0-day 30 after each vaccination
Secondary endpoint
Time frame: Between day 0-6 month after each vaccination
Secondary endpoint
Time frame: Between day 0 to 18 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. However, aggregate study results will be published and reported in accordance with applicable regulations.
Related trials for RSV Immunisation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Hervius Askling, Dr principal investigator
Studieenheten Akademiskt Specialistcentrum
Christian Molnár, Dr principal investigator
Familjeläkarnas Särskilda boenden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing This study examines immune response differences Arexvy between individuals aged 80+ and adults aged 60-65 in people with RSV Immunisation, run by Karin Karin Loré at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint: (time frame: Day 31). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.