AZD6489 Vaccine for RSV Infection
(ARIES Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine, AZD6489, to determine its safety and effectiveness against RSV, a virus causing respiratory infections. Researchers compare two different doses of AZD6489 with two already-approved RSV vaccines. Individuals aged 60 or older with stable health conditions, such as diabetes or high blood pressure, may qualify. The study aims to assess the immune system's response to the vaccine and identify any side effects. As a Phase 1/Phase 2 trial, it focuses on understanding the treatment's function in people and measuring its effectiveness in an initial, smaller group.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the AZD6489 vaccine for RSV is undergoing safety testing and has shown promising early results. Past studies with similar RSV vaccines have generally reported positive safety outcomes. For example, one study found that RSV vaccines like AREXVY effectively prevented RSV-related illness in over 70% of cases. These studies suggest that RSV vaccines can be safe and well-tolerated.
However, since AZD6489 is still under investigation, it is important to note that the current research is in its early stages. The main goal is to understand its safety and tolerability. While specific details about AZD6489’s side effects in humans aren't available yet, these early studies help researchers ensure its safety before moving to larger trials. This careful process protects participants and allows for improvements to the vaccine if needed.12345Why do researchers think this study treatment might be promising?
AZD6489 is unique because it offers a new approach to tackling RSV infections with its novel formulation. Unlike the standard RSV vaccines that are currently available, AZD6489 is being tested in two different doses, allowing researchers to explore optimal dosing for maximum effectiveness. Researchers are excited about AZD6489 because it could provide enhanced protection against RSV with potentially improved immune responses or fewer side effects compared to existing vaccines, making it a promising candidate in the fight against respiratory syncytial virus.
What evidence suggests that this trial's treatments could be effective for RSV infection?
This trial will compare the investigational vaccine AZD6489, administered in different doses, with licensed RSV vaccines. Research has shown that RSV (Respiratory Syncytial Virus) vaccines work by targeting a part of the virus called the F protein, which aids in cell infection. AZD6489 is a new vaccine designed to enhance the immune system's ability to combat RSV using a similar approach. Early studies suggest that vaccines focusing on the prefusion F protein can trigger a strong immune response, aiding in protection against infection. Although direct human data for AZD6489 remains limited, the vaccine’s approach appears promising based on the success of similar vaccines. This method aims to better prepare the body to recognize and fight the virus effectively.678910
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
Citations
Respiratory System: Organs, Facts, Anatomy & Function
Its main function is to breathe in oxygen and breathe out carbon dioxide. It also helps protect you from harmful particles and germs and allows ...
Respiratory Protection - Overview
Assists hospitals in developing and implementing effective respiratory protection programs, with an emphasis on preventing the transmission of aerosol ...
Respiratory Care
The official science journal of the American Association for Respiratory Care (AARC) Improving Outcomes for Tracheostomy Patients … score of 70% in the post- ...
Infection
Find the tests you are missing. Infection mutates your source code and tells you which changes your test suite fails to catch. Get started · Try it online.
The impact of PM2.5 on the human respiratory system - PMC
PM2.5 (particles less than 2.5 micrometers in diameter) can penetrate in the US indicated that the average life span was extended by 0.35 years for every 10 μg ...
Respiratory Syncytial Virus Treatment Market 2034
Treatment is primarily supportive, including hydration, oxygen therapy, and fever management. Preventive measures include good hygiene, ...
Respiratory Syncytial Virus Pipeline Insight | Assessment
The drug is designed as an RNA-dependent RNA polymerase (L protein) inhibitor, meaning it blocks the activity of the RSV L protein, which is essential for viral ...
GSKTrial ID 222253
A study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at ...
Respiratory syncytial virus infection – clinical trials
This maternal RSV vaccine helps protect newborn babies from RSV illness for the first six months of life 5 . The vaccine reduces the risk of RSV hospitalization ...
Respiratory Syncytial Virus (RSV) Vaccine Safety
... Safety Datalink (VSD) for the first season of use of Pfizer RSV vaccine for pregnant people are consistent with clinical trial safety data.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.