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Study of RSVPreF3 vaccine with AS01E adjuvant in adults aged 60-65 and over 80 years to prevent respiratory syncytial virus infection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying Respiratory Syncytial Virus (RSV) infection and testing a vaccine called Arexvy. RSV is a common virus that can cause serious respiratory infections, particularly in older adults. The vaccine contains a specially designed protein from the virus that helps the immune system recognize and fight against RSV.

The study aims to understand how well the vaccine helps the body produce protective substances called neutralizing antibodies against two types of RSV (A and B) in older adults. The vaccine will be given as an injection, with participants receiving up to two doses over a period of 12 months. The vaccine contains a modified form of the virus's protein along with substances that help boost the immune system's response.

During the study, participants will be monitored for their immune response to the vaccine. The research team will also track any reactions at the injection site and throughout the body after vaccination. This includes following up with participants for six months after vaccination to ensure their safety and document any medical events that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial vaccination
You will receive a single dose of Arexvy vaccine through injection
A medical assessment will be performed to confirm your medical stability before vaccination
The vaccination will be administered if you are between 60-65 years old or 80 years and older
Step 2
4-day monitoring period
Your health will be monitored for 4 days after vaccination
You will need to report any reactions at the injection site
You will need to report any general body reactions that occur during this period
Step 3
30-day follow-up
Blood sample collection on day 31 to measure antibody levels against RSV (respiratory syncytial virus)
Monitoring and reporting of any unexpected health effects during the 30-day period after vaccination
Step 4
6-month monitoring period
Regular health monitoring will continue for 6 months after vaccination
Any significant medical events during this period will be recorded
Your health status will be assessed periodically during this time
Step 5
Study completion
Final health assessment
The study will continue until June 30, 2027

Who can join the trial?

9 criteria

Must be born either between 1960-1965 or in or before 1945 at the time of first vaccination
Can live independently in the community or reside in a long-term care facility (a facility providing ongoing medical and personal care)
Must be able to understand and read Swedish
Must be able to provide written consent to receive the Arexvy vaccine
Must be willing and able to follow all study requirements as determined by the study doctor
Must be in stable medical condition at the time of first vaccination, as determined by the study doctor
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Can have stable chronic conditions (long-term health conditions) such as:
- Diabetes (condition affecting blood sugar levels)
- Hypertension (high blood pressure)
- Cardiac disease (heart conditions)

Who cannot join the trial?

15 criteria

Age below 60 years or between 65-80 years old
Previous vaccination against RSV (Respiratory Syncytial Virus)
Currently participating in another clinical trial
History of severe allergic reactions to vaccines
Current acute illness or fever
Weakened immune system from any cause
Taking medications that suppress the immune system
History of serious adverse reaction to any vaccine component
Pregnant or breastfeeding women
Any medical condition that the study doctor determines could interfere with the evaluation of the vaccine
Unable to complete all required study visits
Unable to understand or provide informed consent
Blood disorders that increase risk of bleeding
Recent receipt of blood products or immunoglobulins
Any active or chronic infection requiring treatment

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Verified
Studieenheten Akademiskt Specialistcentrum
Stockholm, Sweden

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Investigated drugs

Arexvy is a vaccine designed to protect against Respiratory Syncytial Virus (RSV). It contains special proteins that help the immune system recognize and fight RSV, particularly strains A and B. The vaccine is specifically formulated for older adults and includes an adjuvant, which is an ingredient that helps strengthen the body's immune response to the vaccine. This vaccine aims to help the immune system produce protective antibodies against RSV infection.

Respiratory Syncytial Virus, Glycoprotein F, Recombinant, Stabilised In The Pre-Fusion Conformation, Adjuvanted With As01E

What is already known about the treatment

Arexvy - A vaccine designed for preventing Respiratory Syncytial Virus (RSV) infections, administered through intramuscular injection. This vaccine specifically targets RSV types A and B and has been developed for use in older adults, particularly those aged 60 years and above. Arexvy works by stimulating the immune system to produce neutralizing antibodies against RSV, helping to protect against severe respiratory infections caused by this virus. The vaccine belongs to the class of adjuvanted protein-based vaccines, which means it contains specific viral proteins combined with substances that enhance the immune response.

Investigated diseases

Respiratory Syncytial Virus (RSV) infection - A common respiratory virus that affects the lungs and breathing passages. RSV typically causes mild, cold-like symptoms including runny nose, coughing, sneezing, and fever. The infection begins in the upper respiratory tract but can spread to the lower respiratory tract. The virus spreads through close contact with infected people or contaminated surfaces. RSV infections can occur year-round but are most common during fall, winter, and spring. The body typically clears the virus within a week or two in healthy individuals.