Randomized, double-blind, phase 2 clinical trial controlled with conventional Bacillus Calmette-Guérin (BCG) vaccine to evaluate the safety and immunogenicity of a recombinant BCG vaccine that expresses the respiratory syncytial virus (RSV) nucleoprotein (N) (rBCG-N-RSV) in adults over 60 years of age.
Researchers are investigating a new version of the BCG vaccine, which traditionally protects against tuberculosis. This updated vaccine, called rBCG-N-RSV, has been modified to also help the body fight off Respiratory Syncytial Virus (RSV), a common cold-like virus that can be serious for older adults. This study aims to check how safe the new vaccine is and how effectively it helps the immune system respond to both tuberculosis and RSV. Participants over 60 years old will receive either the new vaccine or the standard BCG vaccine. Scientists will monitor for any side effects and take blood samples to see the immune response over six months.
At a glance
What is this study about?
This study is a Phase 2 clinical trial looking at a new vaccine designed to tackle two different health concerns: tuberculosis and Respiratory Syncytial Virus (RSV). Tuberculosis is a serious bacterial infection, mainly affecting the lungs. RSV is a common virus that usually causes mild cold-like symptoms, but it can lead to more severe problems, especially in older adults.
The new vaccine, called rBCG-N-RSV, is a modified version of the well-known BCG vaccine. The original BCG vaccine protects against tuberculosis, and this new version has been tweaked to also help your body's immune system fight off RSV. The main goal of this particular study is to find out if this combination vaccine is safe for people over 60 and how well it prepares their immune system to defend against these infections.
Participants in the study will receive either the new rBCG-N-RSV vaccine or the standard BCG vaccine. The researchers will then carefully monitor them over a six-month period. They will look for any side effects from the vaccine and take blood samples to understand how the immune system responds. This will help them determine if the new vaccine could be a promising step forward in protecting older adults from both tuberculosis and RSV.
Key takeaways
- This study is testing a new vaccine designed to protect against both tuberculosis and RSV.
- It involves adults over 60 years old to check vaccine safety and immune response.
- Participants will receive either the new vaccine or the standard tuberculosis vaccine.
- The study lasts six months and involves clinic visits and blood tests.
- It aims to find new ways to protect older adults from important infections.
Who may be eligible?
This study is looking for adults aged 18 and over, of any gender. However, the main focus for this particular trial is on people over 60 years old. This means that while the broader study might accept younger adults, this specific part of the research is concentrating on the older age group to understand how the vaccine works for them.
To be eligible, you would need to be generally healthy and meet other specific health criteria, which the study team would explain in detail. Things that might prevent someone from joining include having certain existing medical conditions, taking particular medications, or having a weakened immune system. The exact rules are very important to make sure the study is safe and that results are clear.
- Are you 18 years old or older?
- Are you over 60 years old?
- Do you generally feel healthy?
- Are you willing to attend clinic visits for six months?
- Are you comfortable with having blood samples taken?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive either the new rBCG-N-RSV vaccine or the standard BCG vaccine in an injection. You wouldn't know which one you received, nor would the doctors giving it – this is called a 'double-blind' study and helps ensure the results are unbiased.
Over the next six months, you would have several visits to the clinic. During these visits, the study team would carefully check for any side effects, both at the injection site and generally, and track how your body reacts to the vaccine. Blood tests would be taken at specific times (before vaccination, and again after 30 days and 180 days) to see how your immune system is responding to the vaccine. The total duration of your active participation, including follow-up, would be six months.
Potential risks and benefits
Locations (1)
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Common questions
What is RSV?
RSV stands for Respiratory Syncytial Virus. It's a common virus that usually causes mild cold-like symptoms, but it can be serious for vulnerable groups, especially older adults.
What is the BCG vaccine?
The BCG vaccine usually protects against tuberculosis, a serious bacterial infection. This study is testing a new version that also aims to protect against RSV.
Why focus on people over 60?
Older adults are often more vulnerable to severe illness from infections like RSV, so testing vaccines in this age group is important to ensure they are safe and effective where they are most needed.
Will I know if I get the new vaccine or the standard one?
No, this is a 'double-blind' study, meaning neither you nor the study doctors will know which vaccine you receive until the study is over. This helps keep the results fair.
How long does the study last?
Your active participation, including clinic visits and follow-up, will last for six months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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