RSV Immunogenicity Study in the Elderly (RISE)

Immunogenicity After a Prime Dose and Revaccination With Adjuvanted RSVPreF3 Vaccine in the Most Elderly and Frail Population - an Open-labeled Phase IIIb-trial

RSV Immunogenicity Study in the Elderly (RISE) (NCT07203365) is a Phase 3 interventional studying RSV Immunisation, sponsored by Karin Karin Loré. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This 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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For RSV Immunisation, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 65 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused RSV Immunisation subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Treatments Being Tested

BIOLOGICAL

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

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.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Familjeläkarna SÄBO

Saltsjöbaden, Sweden

Akademiskt specialistcentrum Studieenheten

Stockholm, Sweden

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07203365), the sponsor (Karin Karin Loré), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07203365 clinical trial studying?

Who can participate in NCT07203365?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07203365?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07203365. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07203365. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.