Recruiting

Effectiveness of respiratory syncytial virus glycoprotein F (pre‑fusion) vaccine adjuvanted with AS01E in preventing RSV‑related respiratory disease hospitalization in adults ≥60 years

Registered drugNo placebo

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What is this trial about?

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

The study focuses on Respiratory syncytial virus infection–related respiratory disease, a viral illness that can cause serious breathing problems, especially in people aged 60 years and older. The intervention being tested is the Arexvy vaccine, which is given as a single injection into the muscle and contains a specially designed protein from the virus to help the immune system recognize and fight the infection.

The purpose of the trial is to determine whether the vaccine can lower the number of hospital stays caused by this virus in the older adult population. Participants will receive either the vaccine or the usual care and will be followed for several months, during which any hospital admission for breathing or heart issues will be recorded. When a hospital stay is suspected to be related to the virus, a laboratory test called PCR—which detects tiny pieces of the virus’s genetic material—will be used to confirm the infection.

Researchers will also track admissions for severe lung infections, heart complications, and worsening of chronic lung conditions such as chronic obstructive pulmonary disease (COPD) and asthma. Throughout the study, safety checks will be performed to monitor any side effects of the vaccine.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After you agree to join the trial, you sign a consent form and receive a study identification number.
Step 2
Baseline assessment
You complete a questionnaire about your health, medical history, and current medications. a brief physical exam may be performed.
Step 3
Vaccination visit
You receive a single intramuscular injection of the arexvy vaccine. the injection contains 120 µg of recombinant rsv glycoprotein f adjuvanted with as01e. the vaccine is given in the upper arm muscle.
The injection is administered once and no further doses of the study vaccine are required.
Step 4
Post‑vaccination observation
You remain at the clinic for about 15–30 minutes so staff can watch for any immediate reactions.
Step 5
Ongoing follow‑up
For the remainder of the study, which may last up to about 20 months, you continue your usual activities.
The study team contacts you periodically, for example by phone, to ask about any respiratory symptoms or hospital visits.
If you are admitted to a hospital for a respiratory problem, the study records the reason and a laboratory test (polymerase chain reaction or antigen test) is performed to confirm rsv infection.
Step 6
Study completion
After the final follow‑up period ends, no further visits are required and the data are analyzed.

Who can join the trial?

3 criteria

Be at least 60 years old (you must be 60 or older).
Live in the Valencian Community (your home address must be in that region of Spain).
Sign and date an informed consent form (a paper that shows you understand the study and agree to take part).

Who cannot join the trial?

6 criteria

You cannot take part if you have a hypersensitivity (a severe allergy) to any of the components of the vaccine.
You cannot take part if you have already received any RSV vaccine before.
You cannot take part if you are already participating in another clinical trial during the study period.
You cannot take part if you are 60 years or older and live in a long‑term care or nursing home facility, because the vaccine is already recommended for people in those settings.
You cannot take part if you have a history of lung transplantation (surgery to replace a lung with a donor lung).
You cannot take part if you have a history of haematopoietic stem cell transplantation, also called a bone‑marrow transplant (a procedure that replaces the blood‑forming cells).

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Investigated drugs

Arexvy is a vaccine that is given as an injection into the muscle. It is designed to help the body’s immune system recognize and fight the respiratory syncytial virus (RSV), which can cause serious breathing problems, especially in older adults. The vaccine contains a tiny, harmless piece of the virus called the “glycoprotein F” that is shaped to look like the form the virus uses to enter cells. This piece trains the immune system without causing disease. The vaccine also includes a special ingredient called an adjuvant (AS01E) that makes the immune response stronger, so the protection lasts longer. In this trial, participants aged 60 and older receive the vaccine to see if it reduces the number of hospital stays caused by RSV‑related respiratory illness.

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

What is already known about the treatment

Arexvy - It is given as a suspension for injection that is administered by intramuscular injection, delivering 120 µg of a recombinant RSV F‑protein combined with the AS01E adjuvant. The vaccine is approved and currently used worldwide to protect older adults against respiratory syncytial virus infection‑related respiratory disease, and it is described in many clinical studies. It works by presenting a stable pre‑fusion form of the RSV F glycoprotein to the immune system, prompting the body to produce antibodies that block the virus from entering cells. Arexvy belongs to the class of recombinant viral subunit vaccines with an adjuvant.

Investigated diseases

Respiratory syncytial virus infection–related respiratory disease - This condition is caused by infection of the airways with respiratory syncytial virus (RSV). It often begins with mild cold‑like symptoms such as runny nose and low‑grade fever. The infection can spread to the lower respiratory tract, leading to coughing, wheezing, and shortness of breath. In older adults, it may worsen existing lung problems, causing more mucus and reduced airflow. Symptoms usually peak within the first week and then gradually lessen over the following days.