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RSV Respiratory Syncytial VirusPhase 1/2ARIESNCT07717840

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

A Phase 1/2 study testing AZD6489, Licensed RSV vaccine #1 and Licensed RSV vaccine #2 in people with RSV Respiratory Syncytial Virus, run by AstraZeneca at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This Phase I/II study is to characterize the safety and immunogenicity of 2 dose levels of AZD6489, an investigational RSV recombinant prefusion F protein VLP vaccine. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
RSV Respiratory Syncytial Virus
What is being tested?
AZD6489, Licensed RSV vaccine #1 and Licensed RSV vaccine #2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
6 sitesUnited States
Study dates
8 Jul 2026to 19 Aug 2027
Phase
Phase 1/2
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

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Research Site

    Chicago, Illinois, 60640

  • Research Site

    Kansas City, Missouri, 64114

  • Research Site

    Lenexa, Kansas, 66219

  • Research Site

    Long Beach, California, 90815

  • Research Site

    Omaha, Nebraska, 68134

  • Research Site

    Rolling Hills Estates, California, 90274

Other trials in United States

About this study

Official title: A Phase I/II, Randomized, Double-Blind, Active-Controlled Study to Characterize the Safety and Immunogenicity of AZD6489 in Adults 60 Years of Age and Older

This Phase I/II study is to characterize the safety and immunogenicity of 2 dose levels of AZD6489, an investigational RSV recombinant prefusion F protein VLP vaccine.

Read the detailed description

This Phase I/II clinical study will be conducted in the US at approximately 5 sites. The study is a randomized, double-blind, active-controlled study to characterize the safety and immunogenicity of a single dose of AZD6489 in adults ≥ 60 years of age. Two dose levels of AZD6489 will be assessed.

Approximately 160 participants will be randomized and stratified by age group and previous receipt of RSV vaccine. Participants will be randomized/dosed to receive AZD6489, licensed RSV vaccine #1, or licensed RSV vaccine #2. The study is split into 2 cohorts based on the 2 dose levels of AZD6489 being studied.

For each cohort, an initial sentinel group of 8 participants will be followed up for safety via a telephone or teleconference call, approximately 48 hours post-study intervention, and the safety data will be evaluated by the SRC in order to provide a recommendation to continue randomization and vaccination for the remaining participants in that cohort.

An ESDR of all available safety data through 7 days post-vaccination of Cohort 1 will be conducted. Randomization of Cohort 2 will be allowed only after the ESDR of Cohort 1 participants has been completed and the results support that the safety profile is acceptable.

This study includes 5 in-clinic study visits. The duration of each participant's involvement in the study will be approximately 12 months following the administration of study intervention. Safety will be assessed for the duration of the study. Blood will be taken for immunological and safety assessments as per SoA.

Being tested
AZD6489, Licensed RSV vaccine #1, Licensed RSV vaccine #2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD6489Biological

    Participants will receive AZD6489 as a single intramuscular injection.

  • Licensed RSV vaccine #1Biological

    Participants will receive licensed RSV vaccine #1 as a single intramuscular injection.

  • Licensed RSV vaccine #2Biological

    Participants will receive licensed RSV vaccine #2 as a single intramuscular injection.

Study groups in NCT07717840
Study groupRoleWhat they receive
AZD6489 Dose AExperimentalParticipants will receive AZD6489 Dose A as a single dose intramuscular injection on Day 1.
Receives: Biological: AZD6489
AZD6489 Dose BExperimentalParticipants will receive AZD6489 Dose B as a single dose intramuscular injection on Day 1.
Receives: Biological: AZD6489
Licensed RSV vaccine #1Active comparatorParticipants will receive licensed RSV vaccine #1 as a single dose intramuscular injection on Day 1.
Receives: Biological: Licensed RSV vaccine #1
Licensed RSV vaccine #2Active comparatorParticipants will receive licensed RSV vaccine #2 as a single dose intramuscular injection on Day 1.
Receives: Biological: Licensed RSV vaccine #2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of immediate unsolicited adverse events (AEs)

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

    Measured: 30 minutes post-study intervention

  2. Incidence of injection site and systemic solicited adverse reactions (ARs)

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

    Measured: Day 1 through 7 days post-study intervention

  3. Incidence of unsolicited adverse events (AEs)

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

    Measured: Day 1 through 28 days post-study intervention

  4. Incidence of serious adverse events (SAEs)

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

    Measured: Day 1 to Day 365

  5. Incidence of adverse events of special interest (AESIs)

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

    Measured: Day 1 to Day 365

  6. Incidence of medically attended adverse events (MAAEs)

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

    Measured: Day 1 to Day 365

  7. RSV A nAb responses to AZD6489

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

    Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start8 Jul 2026
  3. Primary completion1 Oct 2026
  4. Study completion19 Aug 2027 (estimated)

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07717840
Sponsor's protocol ID
D7280C00001
Acronym
ARIES
Status last verified
Oct 2026
First submitted
7 Jul 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AZD6489, Licensed RSV vaccine #1 and Licensed RSV vaccine #2 in people with RSV Respiratory Syncytial Virus, run by AstraZeneca at 6 sites in United States.

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 4 inclusion and 17 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Incidence of immediate unsolicited adverse events (AEs) (time frame: 30 minutes post-study intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07717840.

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 29 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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