RecruitingRSV Respiratory Syncytial Virus
A Study to Characterize the Safety and Immunogenicity of AZD6489 in Participants 60 Years of Age and Older (ARIES)
Eligible age
60+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: AstraZeneca
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
California
Long Beach · Rolling Hills Estates
Illinois
Chicago
Kansas
Lenexa
Missouri
Kansas City
Nebraska
Omaha
Source: ClinicalTrials.gov · NCT07717840 · last updated 2026-07-21