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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 study about?

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.

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

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

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

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

5 Study completion

Final health assessment

The study will continue until June 30, 2027

Who Can Join the Study?

  • 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
  • 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)

    These conditions are acceptable if they are stable and managed with or without treatment

Who Cannot Join the Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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Other Sites

Site Name City Country Status
Szdvqstxjltbt Aactqjnvvs Sjnjraohrebqqoitx Stockholm Sweden
Fuzxtububnltqo i Suvrgjdrohcp Az Saltsjöbaden Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Not yet recruiting
14.04.2025

Trial locations

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 (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.

Trial ID:
2024-520141-23-01
Protocol code:
RISE
Trial Phase:
Therapeutic confirmatory (Phase III)

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