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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Gemeinschaftspraxis Drs. Josef und Wilma Großkopf	Wallerfing	Germany

Other Sites

Site Name	City	Country
Klinische Forschung Berlin-Mitte GmbH	Berlin	Germany
Medizentrum Essen Borbeck	Essen	Germany
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH	Berlin	Germany
KliFoCenter GmbH	Witten	Germany
Klinikum Wuerzburg Mitte gGmbH	Wuerzburg	Germany
Marsg Tbpmud Sa Uq (cjffhgyfsvipzmxyznar	Berlin	Germany
Skhdlfsfudgbdk Mkzkf Mqrlc	Mainz	Germany
Muqnqqsc Gpsb	Weinheim	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	06.05.2024

Trial locations

Investigated drugs:

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

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.

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.

Trial ID:

2023-510190-34-00

Protocol code:

222253

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?