Efficacy of AReSVi Vaccine in the Prevention of Respiratory Synctital Virus Types A and B
Overview / Background
RSV is a common contagious virus affecting the lungs and breathing passages. It is one of the major remaining infectious diseases for which there is currently no vaccine or specific treatment.
Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate conditions including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.
Each year, RSV causes over 360,000 hospitalisations and 24,000 deaths globally in adults.
Adults with underlying conditions are more likely to seek medical advice and have higher hospitalisation rates than adults without these conditions.
Process
The AReSVi 006 phase III trial was a randomised, placebo-controlled, observer-blind, multi-country trial to demonstrate the efficacy of a single dose of GSK's adjuvanted RSVPreF3 OA investigational vaccine in adults aged 60 years and above.
Approximately 25,000 participants were enrolled from 17 countries.
Outcomes
First RSV vaccine candidate to show statistically significant and clinically meaningful efficacy in adults aged 60 years and above
The magnitude of effect observed was consistent across RSV A and B strains, key secondary endpoints and in those aged 70 years and above
Arexyy was licenced by the MHRA, the decision followed the European Commission’s authorisation of Arexvy on 6 June 2023. GSK’s marketing authorisation application in the EU was reviewed under the accelerated assessment mechanism because prevention of RSV illness in the older adult population is considered a major public health interest.
The authorisation is supported by data from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III vaccine efficacy trial, published in the New England Journal of Medicine. In this trial, there was high overall vaccine efficacy against RSV-LRTD, including in participants with certain underlying medical conditions.
The vaccine was generally well tolerated. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, arthralgia, and headache. These were generally mild to moderate and transient.
Arexvy was the world’s first RSV vaccine for older adults to be approved by the US Food and Drug Administration. Regulatory reviews are ongoing in Japan and several other countries.
Additional Information
Recruitment
Target Recruitment: 100 participants
Actual Recruitment: 111 participants
Get Involved
This study has now concluded.
Would you like to participate in an upcoming study?
Click below to send us your details and a member of the team will be in touch.
