Not recruiting

Study on the Immune Response and Safety of RSVPreF3 Vaccine in Adults 18-49 at Risk for Respiratory Syncytial Virus Compared to Adults 60 and Older

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a vaccine for the prevention of Respiratory Syncytial Virus (RSV) Infections. The vaccine being tested is called Arexvy, which is a powder and suspension for injection. It is designed to help the body build a defense against RSV, a virus that can cause respiratory illnesses, especially in people with certain health conditions.

The purpose of the study is to evaluate the immune response and safety of the RSVPreF3 OA investigational vaccine in adults aged 18 to 49 who are at increased risk for RSV disease, compared to older adults aged 60 and above. Participants will receive the vaccine through an injection into the muscle. The study will monitor the immune response to the vaccine and any side effects that may occur.

Participants will be observed over a period of time to assess how their bodies respond to the vaccine. The study aims to ensure that the vaccine is safe and effective for people who are at higher risk of severe RSV infections, such as those with chronic health conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, or diabetes. The study will help determine if the vaccine can provide protection against RSV in these groups.

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
Joining the study
Upon joining the study, you will be required to provide written or witnessed informed consent. This means you agree to participate after understanding the study's purpose and procedures.
If you are under the legal age, written informed assent will also be required, which is a way to confirm your understanding and agreement to participate.
Step 2
Receiving the vaccine
You will receive the Arexvy vaccine, which is a powder and suspension for injection. It is designed to protect against the respiratory syncytial virus (RSV).
The vaccine is administered through an injection into the muscle, known as intramuscular use.
Step 3
Monitoring and follow-up
After receiving the vaccine, you will be monitored for any immediate reactions. This includes checking for any events at the injection site or systemic events, which are reactions that affect the whole body.
You will be asked to keep an electronic diary, known as an eDiary, to record any symptoms or side effects you experience. This helps in tracking your response to the vaccine.
Step 4
Follow-up visits
You will need to attend follow-up visits at the study site. These visits are important for assessing your health and the effectiveness of the vaccine.
During these visits, blood samples may be taken to measure your immune response to the vaccine. This involves checking the levels of antibodies against RSV in your blood.
Step 5
End of study
The study will continue for several months, with the final follow-up visit occurring approximately six months after receiving the vaccine.
At the end of the study, you will have a final assessment to ensure your well-being and to gather any last data needed for the study's conclusions.

Who can join the trial?

21 criteria

Participants and/or their parent(s) or legally authorized representative (LAR) must be able to follow the study requirements, such as completing an electronic diary and attending study visits.
Participants or their parent(s)/LAR must provide written or witnessed informed consent, which means they agree to participate after understanding the study details. If the participant is under the legal age, they must also provide written informed assent, which is their agreement to participate.
For Cohort 1 and Cohort 3: Participants must be between 18-49 years old at the time of the study intervention.
Participants should have at least one of the following stable medical conditions, meaning the condition has not required significant changes in treatment or worsened in the last 3 months:
- Chronic cardiopulmonary disease (long-term heart and lung conditions) with symptoms that limit activity or require long-term medication, such as:
  - Chronic obstructive pulmonary disease (COPD) - a lung disease that makes it hard to breathe.
  - Asthma - a condition where the airways narrow and swell, causing breathing difficulties.
  - Cystic fibrosis - a genetic disorder affecting the lungs and digestive system.
  - Other chronic respiratory diseases like lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema, or bronchiectasis.
  - Chronic heart failure - a condition where the heart doesn't pump blood as well as it should.
  - Coronary artery disease (CAD) - a condition where the heart's blood vessels are narrowed or blocked.
  - Cardiac arrhythmia - an irregular heartbeat that requires medical treatment.
  - Diabetes mellitus (types 1 or 2) - a condition where the body has trouble processing blood sugar, with active treatment for the past 6 months.
  - Other diseases that increase the risk for RSV disease, such as:
    
    Chronic kidney disease - a condition where the kidneys are damaged and can't filter blood as well as they should.
    Chronic moderate to severe liver disease.
    Neurologic or neuromuscular conditions - disorders affecting the brain, spinal cord, or muscles.
    Female participants who cannot become pregnant may join the study.
    Female participants who can become pregnant may join the study if they:
    
    Have used effective birth control for 1 month before the study intervention.
    Have a negative pregnancy test on the day of the study intervention.
    Agree to continue using effective birth control for at least 1 month after the study intervention.
    For Cohort 2: Participants must be over 60 years old at the time of the study intervention.
    Participants with stable chronic medical conditions, such as diabetes, high blood pressure, or heart disease, can join if their condition is stable.
    Participants must live in the general community or in an assisted-living facility where they are mainly responsible for their own care and daily activities.

Who cannot join the trial?

8 criteria

Participants who have a known allergy to any component of the investigational vaccine cannot participate.
Individuals with a history of severe allergic reactions, such as anaphylaxis, to any vaccine or medication are excluded. Anaphylaxis is a serious and rapid allergic reaction that can be life-threatening.
People who have received any other vaccine within 14 days before the study starts are not eligible.
Participants who have a weakened immune system, which means their body has a reduced ability to fight infections, cannot join the study.
Individuals with a history of autoimmune diseases are excluded. Autoimmune diseases are conditions where the immune system mistakenly attacks the body’s own cells.
Pregnant or breastfeeding women are not allowed to participate in the study.
Anyone who has participated in another clinical trial within the last 30 days is not eligible.
Participants with any medical condition that the study doctors believe could interfere with the study results or the participant's safety are excluded.

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Verified sites

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Medizentrum Essen Borbeck
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Essen, Germany

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Investigated drugs

RSVPreF3 OA investigational vaccine is a vaccine being studied to see how well it works in protecting people from a virus called respiratory syncytial virus (RSV). This virus can cause lung infections, especially in people who are at higher risk, like those with certain health conditions. The vaccine is designed to help the body’s immune system recognize and fight off the virus if a person is exposed to it. In this study, researchers are looking at how well the vaccine works in younger adults who are at increased risk for RSV compared to older adults. They are also checking to make sure the vaccine is safe for people to use.

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

What is already known about the treatment

RSVPreF3 OA investigational vaccine – This vaccine is administered as an injection to help protect against Respiratory Syncytial Virus (RSV) infections. It is currently being studied in clinical trials to assess its effectiveness and safety in adults aged 18-49 who are at higher risk of RSV, compared to older adults aged 60 and above. The vaccine works by stimulating the body's immune system to produce antibodies that can fight off the RSV virus. It belongs to the class of vaccines designed to prevent viral infections by enhancing the immune response.

Investigated diseases

Respiratory Syncytial Virus Infections – Respiratory Syncytial Virus (RSV) infections are caused by a virus that primarily affects the respiratory tract. The virus is highly contagious and spreads through droplets from coughs or sneezes. Infections often begin with symptoms similar to a common cold, such as a runny nose, cough, and fever. As the disease progresses, it can lead to more severe respiratory issues, especially in infants and older adults, including bronchiolitis and pneumonia. The virus can cause inflammation and obstruction of the small airways in the lungs, leading to difficulty breathing. Recovery from the infection can take a few weeks, with symptoms gradually improving over time.