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Study on the Immune Response and Safety of an RSV Vaccine in Immunocompromised Patients Aged 18 and Older Using Arexvy and Saline

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What is this study about?

This clinical trial is focused on studying the effects of a vaccine for Respiratory Syncytial Virus (RSV), a virus that can cause respiratory infections, especially in people with weakened immune systems. The treatment being tested is called Arexvy, which is a vaccine designed to help the body build a defense against RSV. The study will also use saline, a simple saltwater solution, as a comparison.

The purpose of the study is to evaluate how the immune system responds to one or two doses of the Arexvy vaccine in people who have weakened immune systems and are 18 years or older. Participants will receive the vaccine through an injection into the muscle. The study will monitor the immune response by measuring specific antibodies, which are proteins the body makes to fight infections, over a period of time. The study will also look at the safety of the vaccine by checking for any side effects that might occur after the injections.

Participants will be observed for changes in their immune response and any side effects for up to 12 months after receiving the vaccine. The study aims to understand how well the vaccine works in boosting the immune system’s ability to fight RSV and to ensure it is safe for use in people with compromised immune systems. This information will help in developing better protection against RSV for those who are most at risk.

1 initial vaccination

You will receive your first dose of the Arexvy vaccine through an intramuscular injection. This vaccine is designed to help your body build a defense against the respiratory syncytial virus (RSV).

The vaccine is a suspension for injection, which means it is a liquid that is injected into your muscle.

2 monitoring after first dose

After receiving the first dose, you will be monitored for any immediate reactions. This monitoring period lasts for a short time after the injection.

You will be asked to report any side effects or unusual symptoms you experience in the days following the injection.

3 second vaccination

You will receive a second dose of the Arexvy vaccine through another intramuscular injection. This is to further strengthen your body’s defense against RSV.

The timing of this second dose will be determined by the study schedule, typically 30-60 days after the first dose.

4 monitoring after second dose

Similar to the first dose, you will be monitored for any immediate reactions after the second injection.

You will continue to report any side effects or unusual symptoms you experience in the days following the second injection.

5 follow-up visits

You will have several follow-up visits scheduled over the course of the study. These visits are important to track your body’s response to the vaccine.

During these visits, blood samples may be taken to measure the levels of antibodies, which are proteins your body makes to fight the virus.

6 final assessment

At the end of the study period, a final assessment will be conducted. This will include a review of your health and any changes since the start of the study.

The study aims to understand how well the vaccine works in building immunity against RSV in people with weakened immune systems.

Who Can Join the Study?

  • Participants must be at least 18 years old.
  • Participants must have a condition related to the Respiratory syncytial virus.
  • Participants must be able to understand and follow the study requirements, as judged by the study doctor.
  • Participants must be able to provide written consent before joining the study and before any study-specific procedures are done.
  • Female participants who can have children must use effective birth control starting one month before the first vaccine dose and continue for at least one month after the last vaccine dose. They must also have a negative pregnancy test on the day of the first vaccination.
  • Female participants who cannot have children can join the study. This includes women who have had a hysterectomy (surgical removal of the uterus) or are post-menopausal (have stopped having periods).
  • Participants living in the community or in an assisted-living facility with minimal help can join, as long as they can take care of themselves and perform daily activities.
  • Participants with long-term medical conditions, whether they are receiving treatment or not, can join if the study doctor considers them to be medically stable.

Who Cannot Join the Study?

  • Patients who are not immunocompromised. This means your immune system is not weakened or less able to fight infections.
  • Patients under 18 years of age.
  • Patients who have not received the first dose of the Arexvy vaccine.
  • Patients who are not willing to receive a second dose of the Arexvy vaccine.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria

Other Sites

No sites found in this category

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
15.08.2024

Trial locations

Investigated drugs:

Arexvy is a vaccine designed to protect against respiratory syncytial virus (RSV). It works by helping your immune system recognize and fight the virus if you are exposed to it. This vaccine is especially important for people with weakened immune systems, as they are more vulnerable to infections. In this study, researchers are looking at how well the vaccine works after one or two doses in people who are 18 years or older and have compromised immune systems. The goal is to see if the second dose provides a stronger immune response compared to just one dose.

Respiratory Syncytial Virus – Respiratory Syncytial Virus (RSV) is a common virus that infects the respiratory tract, particularly affecting the lungs and breathing passages. It typically begins with symptoms similar to a mild cold, such as a runny nose, cough, and fever. As the infection progresses, it can lead to more severe respiratory issues, especially in infants and older adults, including bronchiolitis and pneumonia. The virus spreads through droplets from coughs or sneezes and can survive on surfaces, making it highly contagious. In most cases, symptoms resolve within one to two weeks, but the virus can cause significant discomfort and breathing difficulties during this period. RSV is a seasonal virus, with outbreaks commonly occurring in the fall and winter months.

Trial ID:
2024-513187-25-00
Protocol code:
ISPTM-RSV-001
NCT ID:
NCT06597916
Trial Phase:
Therapeutic exploratory (Phase II)

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