AZD6489 Vaccine for RSV Infection

(ARIES Trial)

Not currently recruiting at 5 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I am able to understand and sign the consent form for this study.
I am 60 years old or older.
Participants who are medically stable in the opinion of the Investigator at the time of study intervention, including those with chronic stable medical conditions such as diabetes, hypertension, or cardiac disease if considered medically stable
See 1 more

Exclusion Criteria

Known or suspected congenital or acquired immunodeficiency
Chronic illness that might interfere with study conduct or completion in the opinion of the Investigator
I have received a vaccine in the last 28 days or plan to get one soon.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of AZD6489 or a licensed RSV vaccine

1 day
1 visit (in-person)

Initial Safety Follow-up

Participants are monitored for immediate and short-term adverse events post-vaccination

7 days
1 follow-up call (virtual)

Extended Follow-up

Participants are monitored for safety and immunogenicity, including serious adverse events and nAb responses

12 months
4 visits (in-person)

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

Group I: AZD6489 Dose BExperimental Treatment1 Intervention
Group II: AZD6489 Dose AExperimental Treatment1 Intervention
Group III: Licensed RSV vaccine #1Active Control1 Intervention
Group IV: Licensed RSV vaccine #2Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

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