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Tests treatment safety and results for RSV Respiratory Syncytial Virus
Official title A Study to Characterize the Safety and Immunogenicity of AZD6489 in Participants 60 Years of Age and Older (ARIES)
ClinicalTrials.gov ID: NCT07717840
What this study is testing
What is AZD6489?
AZD6489 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for rsv respiratory syncytial virus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- Able to understand and comply with study requirements/procedures including attending all scheduled study visits (if applicable, with assistance by...
- Capable of giving signed informed consent as described in Appendix A 3 which includes compliance with the requirements and restrictions listed in the...
You likely can't join 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...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- Rolling Hills Estates, California, United States
- Chicago, Illinois, United States
- Lenexa, Kansas, United States
- Kansas City, Missouri, United States
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Beach, California, United States; Rolling Hills Estates, California, United States; Chicago, Illinois, United States; Lenexa, Kansas, United States; Kansas City, Missouri, United States; Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.