AZD6489 Vaccine for RSV Infection
(ARIES Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for people aged 60 or older who are medically stable, including those with well-controlled chronic conditions. Participants must not have immune system problems, recent serious illnesses, certain cancers, recent vaccines or immunosuppressive treatments, severe allergies to vaccines, or a history of Guillain-Barré syndrome.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of AZD6489 or a licensed RSV vaccine
Initial Safety Follow-up
Participants are monitored for immediate and short-term adverse events post-vaccination
Extended Follow-up
Participants are monitored for safety and immunogenicity, including serious adverse events and nAb responses
What Are the Treatments Tested in This Trial?
Interventions
- AZD6489
Trial Overview
The study is testing two dose levels of an experimental RSV vaccine (AZD6489) compared to two already approved RSV vaccines in adults over 60. The main goals are to check safety and how well the body responds to these vaccines.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants will receive AZD6489 Dose B as a single dose intramuscular injection on Day 1.
Participants will receive AZD6489 Dose A as a single dose intramuscular injection on Day 1.
Participants will receive licensed RSV vaccine #1 as a single dose intramuscular injection on Day 1.
Participants will receive licensed RSV vaccine #2 as a single dose intramuscular injection on Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
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