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A Study of AZD6489 for RSV in Older Adults (ARIES)

This study, called ARIES, is looking at a new vaccine called AZD6489 for Respiratory Syncytial Virus (RSV) in people aged 60 and older. Researchers want to understand how safe AZD6489 is and how well it helps your body create protection against RSV. You might receive AZD6489 or one of two already approved RSV vaccines. The study will enroll about 160 participants. Success in this study means seeing how often people have side effects (adverse events) right after the injection, in the first week, and within the first month. This helps researchers understand the vaccine's safety profile.

Study design
This is a Phase I/II, randomized, double-blind, active-controlled study. It will involve approximately 160 participants who will be randomly assigned to receive one of the study interventions.
What's involved
You will have 5 in-clinic study visits. Your safety will be checked through phone calls after 48 hours and through follow-up for up to 28 days after the injection.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for immediate side effects (30 minutes post-injection), injection site and body-wide reactions (up to 7 days post-injection), and other side effects (up to 28 days post-injection).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07717840

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

Recruiting
PHASE1Ages 60+InterventionalPrevention
AstraZeneca
~160 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:AZD6489Licensed RSV vaccine #1Licensed RSV vaccine #2

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of immediate unsolicited adverse events (AEs)
Measured over 30 minutes post-study intervention
+6 more outcomes measured

Conditions

RSV Respiratory Syncytial Virus

Explore related trials

Respiratory Syncytial Virus

Where it's being run

6 sites across 5 states
California2
Illinois1
Kansas1
Missouri1
Nebraska1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant must be ≥ 60 years of age at the time of signing the informed consent.
Participants who are medically stable in the opinion of the Investigator at the time of study intervention. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension, or cardiac disease, are allowed to participate in this study if considered by the Investigator as medically stable.
Able to understand and comply with study requirements/procedures including attending all scheduled study visits (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined) based on the assessment of the Investigator.
Capable of giving signed informed consent as described in Appendix A 3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion

Previous known laboratory-confirmed RSV infection within 6 months of Visit 1.
Moderate to severe acute (time-limited) or any febrile (temperature ≥ 38.0 °C \[100.4 ºF\]) illness/infection within 3 days of Visit 1; participants excluded for transient acute illness may be rescreened once and vaccinated if the illness has resolved.
History of a clinically significant bleeding disorder contraindicating IM injections or venipuncture based on Investigator judgment.
History of hypersensitivity to any component of the study interventions.
History of severe adverse reaction or severe allergic reaction (eg, anaphylaxis) associated with any vaccine.
Known chronic hepatitis B or C.
Known or suspected congenital or acquired immunodeficiency.
History of Guillain-Barré syndrome or any other demyelinating condition.
Current or previous (within the past 5 years) history of any malignancy (except treated non-melanoma skin cancers, locally treated cervical cancer, or prostate cancer that is stable at the time of vaccination in the absence of therapy).
Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
Receipt of any licensed or investigational RSV vaccine within 2 years prior to Visit 1, or planned receipt during the study.
Receipt of any licensed vaccine (including licensed influenza or COVID-19 vaccines) within 28 days prior to Visit 1 or expected receipt prior to end of Visit 3 assessments.
Receipt of immunoglobulin or blood products within 3 months prior to Visit 1, or planned receipt during the study.
Receipt of immune-modifying drugs or immunosuppressive therapy (eg, anti-cancer chemotherapy, anti-cytokine therapy, or radiation therapy) within 6 months prior to Visit 1, or planned receipt during study.
Long-term systemic corticosteroid therapy (prednisone or equivalent at a dose of ≥ 20 mg daily or every other day for more than 2 consecutive weeks) within 6 months prior to Visit 1 or planned receipt during study. Topical/inhaled/intra-articular/ophthalmic/otic steroids or short-term oral steroids are permitted.
Receipt of allergen immunotherapy if dose has been escalated or reduced within 30 days of Visit 1. Allergen immunotherapy is allowed if participant is receiving stable desensitization therapy for at least 30 days prior to Visit 1 and there is no anticipated change before Visit 3.
Participation in another clinical study with a study intervention administered in the preceding 90 days (or preceding 6 months for extended half-life drug products) or expected receipt of another study intervention during the study, or concurrent participation in another interventional study. Individuals who are in a prolonged post-administration observation period of another investigational, marketed drug, or non-interventional clinical study, for which there is no ongoing exposure to the investigational or marketed product and all scheduled on-site visits are completed, will be allowed to take part in this study, if all other eligibility criteria are met.

What this trial measures

  • Incidence of immediate unsolicited adverse events (AEs)30 minutes post-study intervention

    To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines

  • Incidence of injection site and systemic solicited adverse reactions (ARs)Day 1 through 7 days post-study intervention

    To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines

  • Incidence of unsolicited adverse events (AEs)Day 1 through 28 days post-study intervention

    To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines

  • Incidence of serious adverse events (SAEs)Day 1 to Day 365

    To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines

  • Incidence of adverse events of special interest (AESIs)Day 1 to Day 365

    To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines

  • Incidence of medically attended adverse events (MAAEs)Day 1 to Day 365

    To assess the safety of a single IM vaccination with AZD6489 or licensed RSV vaccines

  • RSV A nAb responses to AZD6489Day 29

    To characterize the nAb responses to RSV A in serum following a single IM vaccination with AZD6489