What is AZD6489 studying for RSV in older adults?

AZD6489 is being studied to evaluate its safety and ability to trigger an immune response against respiratory syncytial virus (RSV) in adults aged 60 and older. This study compares two doses of AZD6489 with two licensed RSV vaccines. AstraZeneca sponsors this research to better understand vaccine options for RSV prevention.

Who may be eligible for this RSV vaccine clinical trial?

Adults aged 60 years or older who are medically stable, including those with treated chronic conditions like diabetes or heart disease, may be eligible. Participants must not have had an RSV infection in the past 6 months or received another RSV vaccine recently. This trial accepts all genders. Please review eligibility criteria for more details.

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

Study-related care, including the vaccine and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 60Years +

All Genders

Healthy Volunteers

ID07717840

Evaluating Safety and Immune Response of AZD6489 RSV Vaccine Compared to Licensed Vaccines in Adults 60 and Older

Led by AstraZeneca · Updated on 2026-07-21

160

Participants Needed

Research Sites

46 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and immune response of AZD6489, an investigational RSV recombinant prefusion F protein virus-like particle vaccine, in adults aged 60 years and older. This randomized, double-blind, active-controlled Phase III study aims to understand the effects of two different dose levels of AZD6489 compared to two licensed RSV vaccines. The study includes about 160 participants and is conducted at around five sites in the US. Participants will be randomly assigned to receive a single intramuscular injection of either AZD6489 at one of two dose levels, licensed RSV vaccine 1, or licensed RSV vaccine 2. The study is divided into two cohorts, each focusing on a different dose level of AZD6489. Safety is closely monitored, starting with a small sentinel group in each cohort, followed by broader participant vaccination after safety reviews. The study involves five clinic visits over approximately 12 months. During the study, participants will undergo safety assessments including monitoring for adverse events immediately after vaccination and for up to one year. Blood samples will be collected to evaluate immune responses and safety markers. The main outcomes measured include the incidence of adverse events and antibody responses to RSV at day 29. Participants will be followed throughout the study duration to monitor health and vaccine effects.

CONDITIONS

Brief Title

A Study to Characterize the Safety and Immunogenicity of AZD6489 in Participants 60 Years of Age and Older (ARIES)

Who Can Participate

Age: 60Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Participant must be 60 years of age or older at the time of informed consent.
Participants must be medically stable, including those with chronic conditions such as diabetes, hypertension, or cardiac disease.
Able to understand and follow study procedures, including attending all scheduled visits with assistance if needed.
Capable of providing signed informed consent and complying with study requirements.

You will not qualify if you...

Confirmed RSV infection within 6 months before the first visit.
Moderate to severe acute illness or fever of 38.0°C (100.4°F) or higher within 3 days before the first visit.
History of significant bleeding disorder preventing injections or blood draws.
Known allergy or severe reaction to any vaccine components.
History of severe allergic reaction to vaccines.
Known chronic hepatitis B or C infection.
Known or suspected immunodeficiency.
History of Guillain-Barré syndrome or other demyelinating conditions.
Current or recent (within 5 years) malignancy except certain treated cancers considered stable.
Chronic illness that could interfere with study participation.
Receipt of any RSV vaccine within 2 years before the study or planned vaccination during the study.
Receipt of any licensed vaccine within 28 days before the study or expected during initial assessments.
Receipt of immunoglobulin or blood products within 3 months before the study or planned during the study.
Use of immune-modifying or immunosuppressive therapy within 6 months before the study or planned during the study.
Long-term systemic corticosteroid therapy within 6 months before the study or planned during the study.
Recent changes in allergen immunotherapy dose within 30 days before the study.
Participation in another clinical study with intervention within 90 days (or 6 months for some drugs) before or during this study.

Research Team

AstraZeneca Clinical Study Information Center

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Evaluating Safety and Immune Response of AZD6489 RSV Vaccine Compared to Licensed Vaccines in Adults 60 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