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Study on the Safety and Immune Response of rBCG-N-RSV Vaccine Compared to BCG Vaccine in Adults Over 60 with Respiratory Syncytial Virus (RSV) Concerns

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 the safety and immune response of a new vaccine called rBCG-N-RSV in adults over 60 years old. The trial compares this new vaccine to the conventional Bacillus Calmette-Guérin (BCG) vaccine, which is commonly used to protect against tuberculosis. The new vaccine, rBCG-N-RSV, is designed to also target the Respiratory Syncytial Virus (RSV), a virus that can cause respiratory infections.

The purpose of the study is to evaluate how safe the new vaccine is and how well it triggers an immune response compared to the traditional BCG vaccine. Participants in the study will receive either the new vaccine or the conventional BCG vaccine through a small injection into the skin. The study will monitor participants over a period of time to observe any side effects and to measure the body's immune response to the vaccines.

Throughout the study, researchers will collect information on any side effects experienced by participants and will analyze blood samples to assess the immune response. The study aims to provide valuable information on whether the new vaccine can offer additional protection against RSV while maintaining the benefits of the traditional BCG vaccine. This research is important for understanding how to better protect older adults from respiratory infections.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial vaccination
Upon joining the study, you will receive an injection of the rBCG-N-RSV vaccine or the conventional BCG vaccine. This is done through a method called intradermal use, which means the vaccine is injected just under the skin.
The vaccine contains live bacteria that have been weakened so they do not cause disease. The purpose is to evaluate the safety and immune response in adults over 60 years of age.
Step 2
Monitoring and follow-up
After receiving the vaccine, you will be monitored for any immediate reactions. This includes checking for any local reactions at the injection site, such as redness or swelling, and any other side effects.
You will have regular follow-up visits over a period of 6 months. During these visits, the research team will check your health and collect information about any side effects you may experience.
Step 3
Blood tests
Throughout the study, blood samples will be taken to assess your immune response to the vaccine. This involves measuring specific proteins in your blood that indicate how your body is responding to the vaccine.
The blood tests will help determine the levels of certain immune cells and proteins, such as IFN-γ, TNF-α, IL-2, IL-4, Granzyme B, and IL-10, which are important for understanding your immune response.
Step 4
Final assessment
At the end of the 6-month period, a final assessment will be conducted. This will include a comprehensive review of your health and any side effects experienced during the study.
The research team will also evaluate the overall immune response to the vaccine by analyzing the data collected from your blood tests and health assessments.

Who can join the trial?

9 criteria

Has completed the written informed consent process.
Males or females, over 60 years of age as of the date of signature of the informed consent form.
Has a stable state of health or controlled chronic diseases (health conditions that are managed and within normal limits) that do not fall within the exclusion criteria.
Willingness to comply with study procedures.
No plans to move to another city in the next 6 months and willing to be contacted by the research team within the study period.
Not participate in another research study in the previous 3 months, nor plans to participate in another research study in the next 6 months.
Agrees to avoid elective surgery (planned, non-emergency surgery) during the study.
Willingness to receive HIV test results.
Not having received a BCG vaccination (a vaccine primarily used against tuberculosis) within the last 10 years before study vaccination.

Who cannot join the trial?

9 criteria

Adults under the age of 60 cannot participate.
Individuals with a weakened immune system are not eligible. This means if your body's defense system is not strong enough to fight infections, you cannot join.
People who have had a severe allergic reaction to any vaccine in the past should not participate. An allergic reaction can include symptoms like swelling, difficulty breathing, or a rash.
Participants should not have any serious chronic illnesses. Chronic illnesses are long-lasting health conditions like heart disease or diabetes.
Individuals who are currently participating in another clinical trial are not allowed to join.
Pregnant or breastfeeding women cannot take part in the study.
Anyone who has received a live vaccine within the last 4 weeks is not eligible. Live vaccines contain a small amount of the living virus or bacteria.
People with a history of drug or alcohol abuse in the past year are excluded. Abuse means using these substances in a way that is harmful to your health.
Individuals with any condition that, in the opinion of the study doctor, might interfere with the study results or the participant's safety are not eligible.

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Verified sites

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Laiko General Hospital Of Athens
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Athens, Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
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Chaidari, Greece

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Investigated drugs

Recombinant BCG Vaccine Expressing RSV Nucleoprotein (rBCG-N-RSV)
is a new type of vaccine being tested in this clinical trial. It is designed to help the body build a defense against two different infections: tuberculosis and respiratory syncytial virus (RSV). This vaccine is made by taking a traditional BCG vaccine, which is usually used to protect against tuberculosis, and adding a small part of the RSV virus to it. The goal is to see if this new vaccine can safely help older adults develop a strong immune response to both tuberculosis and RSV.
Conventional BCG Vaccine
is the standard vaccine used to protect against tuberculosis. It has been used for many years and is known to help the body fight off the bacteria that cause tuberculosis. In this trial, the conventional BCG vaccine is used as a comparison to see how well the new recombinant BCG vaccine works. The study aims to understand if the new vaccine can provide additional protection against RSV while still offering the same level of protection against tuberculosis as the conventional BCG vaccine.

What is already known about the treatment

rBCG-N-RSV – This medication is administered as an injection and is currently being studied in a Phase 2 clinical trial to assess its safety and immune response in adults over 60 years old. It is a recombinant vaccine that combines the Bacillus Calmette-Guérin (BCG) vaccine with a protein from the respiratory syncytial virus (RSV). The main purpose of this vaccine is to boost the body's immune system to fight against RSV infections. At the molecular level, it works by stimulating the immune system to recognize and respond to the RSV nucleoprotein, potentially providing protection against the virus. This vaccine falls under the category of immunological agents, specifically designed to enhance the body's defense mechanisms.

Investigated diseases

Respiratory Syncytial Virus Infection – Respiratory Syncytial Virus (RSV) infection is a common respiratory virus that affects 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 older adults and those with weakened immune systems. The virus can cause inflammation of the small airways in the lungs, leading to wheezing and difficulty breathing. In severe cases, it may result in bronchiolitis or pneumonia. The infection is highly contagious and spreads through respiratory droplets.