A randomized, Phase I, single-center, observer-blind, active-controlled study to evaluate the safety, tolerability and immunogenicity of one single administration of PCV-LITE, a novel adjuvanted pneumococcal conjugate vaccine at one dose level of LiteVax Adjuvant, in healthy participants aged 18-50 years.
This research is looking at a new vaccine designed to protect against conditions caused by pneumococcal bacteria, such as pneumonia and blood infections. It's called PCV-LITE and includes a special ingredient to help the vaccine work better. This is an early-stage study, meaning it's one of the first times this vaccine is being given to people. We are inviting healthy adults between 18 and 50 years old to take part. The main goals are to see how safe the vaccine is, how well people tolerate it, and how their immune system reacts to create protection. This information will help us decide if it's safe to test in more people.
At a glance
What is this study about?
This study is about creating a new vaccine to prevent serious illnesses caused by a type of germ called pneumococcus. These germs can lead to nasty infections like pneumonia (a type of lung infection) and even severe blood infections. Existing vaccines are good, but scientists are always trying to make them better or more widely available.
This new vaccine is called PCV-LITE. It's a special kind of vaccine that has something extra mixed in, called an 'adjuvant'. This adjuvant acts like a boost, helping your body's immune system react more strongly to the vaccine, which could mean better or longer-lasting protection against the germ.
This is a 'Phase I' study, which is the very first step in testing a new medicine or vaccine in people. It's a small study focused intensely on safety. We want to make absolutely sure it's safe and doesn't cause unexpected problems in healthy volunteers. We'll also be looking closely at how the body reacts to the vaccine to start building protection. The results from this study will be crucial in deciding if we can continue testing this vaccine in larger groups of people.
Key takeaways
- This is a first-time-in-humans study for a new pneumococcal vaccine called PCV-LITE.
- It's for healthy adults aged 18 to 50 years.
- The main goals are to check vaccine safety and how the immune system responds.
- Participation involves one vaccine dose and follow-up visits with blood tests.
- You would be helping to develop new ways to prevent serious infections.
Who may be eligible?
To join this study, we are looking for healthy adults. You must be at least 18 years old, and there is no upper age limit, though the study description focuses on adults up to 50 years. Both men and women are welcome to take part.
Being 'healthy' for a study like this generally means you don't have any serious ongoing medical conditions, you're not taking certain medications that could interfere with the vaccine, and you haven't recently had certain illnesses or treatments. The study team will do a thorough health check to make sure it's safe for you.
If you have particular allergies, certain medical conditions, or are pregnant or breastfeeding, you might not be able to join. The study doctors will talk you through all the specific details to make sure this is the right and safe option for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 50 years old?
- Are you generally healthy with no serious ongoing medical conditions?
- Are you willing to attend regular follow-up appointments?
- Are you comfortable with blood tests?
- Are you not currently pregnant or breastfeeding?
What does participation involve?
If you decide to take part, you would receive one dose of the new vaccine. You'll have several visits to the study clinic where doctors and nurses will check your health, ask about any side effects, and take blood samples. These samples help us understand how your immune system is responding to the vaccine.
There will be an initial screening visit to check if you're suitable. After receiving the vaccine, you'll likely have follow-up visits over a few weeks or months. During these visits, the medical team will keep a close eye on you. The total time you'd be involved in the study from your first visit to your last check-up would be explained to you in detail before you agree to take part.
Potential risks and benefits
Locations (1)
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Common questions
What is pneumococcal infection?
It's an illness caused by bacteria that can lead to serious lung infections (pneumonia), ear infections, and even severe blood infections.
What does 'Phase I' mean?
It's the first time a new medicine or vaccine is tested in people. The main goal is to check its safety and how the body reacts to it.
Will I get the actual vaccine or a dummy shot?
Because this study uses an 'active-controlled' design, you will either receive the new vaccine or an existing, approved vaccine for pneumococcal infection, not a dummy shot.
Will I know if I got the new vaccine?
No, this is an 'observer-blind' study, meaning the people checking your health won't know which vaccine you received, to keep the results fair and unbiased.
Do I have to pay to join?
No, participation in clinical trials is free. Expenses for travel might be covered, but this would be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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