A study to assess the safety and immunogenicity of a therapeutic hepatitis B virus vaccine, in healthy adults (RUBY).
Hepatitis B is a virus that infects the liver and can lead to serious long-term illness. While routine vaccines protect people from catching the virus, scientists are developing a 'therapeutic vaccine' designed to help treat people who already have the infection. The RUBY study is a Phase 1 clinical trial, which means it is the first time this new vaccine is being given to humans. Before testing it in people living with hepatitis B, doctors need to make sure it is safe and see how the body reacts. To do this, they are testing it in healthy adult volunteers. Participants will receive the study vaccine and attend regular clinic visits. Doctors will track their health, watch for any side effects, and take blood tests to see if the immune system responds as expected. Taking part helps researchers take an essential step toward finding better hepatitis B treatments.
At a glance
What is this study about?
Hepatitis B is a common virus that attacks the liver. While many people recover on their own, some develop a chronic (long-term) infection that can cause liver scarring, liver failure, or liver cancer. Current medicines can keep the virus under control, but they rarely cure it, meaning people often need to take tablets every day for the rest of their lives.
This trial is investigating a 'therapeutic vaccine'. Unlike traditional vaccines, which train the body to prevent an infection before it happens, a therapeutic vaccine aims to boost the immune system so it can fight off an infection that is already established. The goal is to help the body clear the virus for good.
The RUBY study is an early-stage trial known as a Phase 1 or 'first-in-human' study. Because this vaccine has never been tested in people before, researchers must first give it to a small group of healthy volunteers. This allows the study team to carefully check the vaccine's safety, look for any unwanted side effects, and measure how the immune system responds before testing it in patients with chronic hepatitis B.
Taking part in this study does not treat an existing illness for the volunteer, but it provides vital information. If the vaccine proves to be safe and shows good immune activity, it can move forward into larger studies involving people who live with chronic hepatitis B, potentially leading to new life-changing treatments.
Key takeaways
- The RUBY study is testing a new therapeutic hepatitis B vaccine for the first time in humans.
- It is looking for healthy adult volunteers aged 18 and older.
- The main goal is to test the vaccine's safety and check how the immune system responds.
- There is no direct health benefit for participants, but the trial helps advance hepatitis B research.
- Taking part involves clinic visits, health checks, an injection, and regular blood tests.
Who may be eligible?
This trial is looking for healthy adults aged 18 and older. Because this is the first time the vaccine is being tested in humans, volunteers must be in good general health. This ensures that any reactions or side effects can be clearly understood without being confused by other medical conditions.
You cannot take part if you currently have hepatitis B, hepatitis C, or HIV, or if you have serious long-term health problems such as severe heart, kidney, or liver disease. People with conditions that weaken the immune system, or those taking medications that affect immunity (such as high-dose steroids), are also unable to join.
Women who are pregnant, planning to become pregnant, or breastfeeding will not be eligible. The study doctor will carry out detailed medical checks, including blood tests and a physical exam, to confirm whether taking part is safe and suitable 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.
- I am at least 18 years old.
- I consider myself to be in good overall health.
- I do not have hepatitis B, hepatitis C, or HIV.
- I do not have a condition or take medicine that affects my immune system.
- I am not pregnant, planning a pregnancy during the study, or breastfeeding.
- I am willing and able to attend all planned clinic visits and blood tests.
What does participation involve?
Taking part in the study involves several stages over a set period, typically lasting a few months. First, you will attend a screening visit where the team checks your medical history, performs physical checks, and takes blood and urine samples. If you are eligible and choose to take part, you will receive the study vaccine, usually given as an injection into a muscle, such as in your upper arm. After the injection, you will be monitored closely in the clinic for a short period to ensure you feel well. Over the following weeks and months, you will return for regular clinic appointments. During these visits, the doctors will check for any side effects, ask about how you are feeling, and take blood samples to measure your body's immune response. You will also be asked to keep a record or diary of any symptoms you notice at home.
Potential risks and benefits
Locations (1)
- —UnverifiedBelgium
Common questions
Do I need to have hepatitis B to join this study?
No. This trial is specifically for healthy volunteers who do not have hepatitis B, to test the safety of the vaccine first.
Will this vaccine protect me from catching hepatitis B in the future?
You should not rely on this study vaccine for protection. It is a therapeutic vaccine being tested for safety, not an approved preventative vaccine.
Why is the vaccine being tested on healthy people first?
Testing in healthy volunteers helps doctors see how the vaccine behaves on its own, making it easier to spot side effects and measure immune responses safely.
Will I be paid or reimbursed for taking part?
Phase 1 trials in healthy volunteers often provide compensation for your time and travel expenses. The study team can give you full details about this.
What happens if I change my mind during the trial?
You can leave the study at any point. Your decision will always be respected, though the study team may recommend a final safety checkup.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.