Hepatitis B Vaccine Study (HBV001)
HEPATITIS B VACCINE STUDY (HBV001)
What is the purpose of this trial?
Approximately 5-10% of the adults who get infected with Hepatitis B virus (HBV), cannot clear the virus and they develop chronic liver disease. Chronic hepatitis B is estimated to increase the risk of liver cancer. Highly effective prophylactic vaccines were implemented in the early 1980's; however, these vaccines are ineffective once infection is established. Despite the wide use of prophylactic vaccines, there are an estimated 240 million chronic hepatitis B carriers and over 686,000 related deaths per year worldwide. Our research program is aiming to study new treatment concepts that focus on the clearance of HBsAg stimulating the immune system.
The aim of the study is to see if the vaccine is safe and to see if it induces an immune response against hepatitis B Virus infection.
Am I eligible to participate?
What does the trial involve?
During this study, 22 individuals will be vaccinated, out of which 10 will be healthy volunteers and 12 will be patients on treatment for chronic Hepatitis B. Each participant will receive one vaccination; After the vaccine, volunteers will be followed up for an additional 6 months (total number of visits 9).
Vaccine appointments usually last around 90 minutes, and follow-up appointments around 20 minutes.
Is there any reimbursement for the trial?
You will receive compensation for your time, travel and inconvenience. If you participate in the study until the end, you will receive a total payment of £345.
What are the advantages of taking part?
Knowledge gained from this study will help us understand and develop new treatment concepts that focus on the clearance of HBsAg stimulating the immune system and may in the future help others treat Hep B infection. There are no direct benefits of taking part, however you will receive a full medical examination at your screening appointment as part of the study.
Are there any risks from taking part in the study?
Although this is the first time this vaccine has been administered to humans, similar investigational vaccines have been widely administered for many pathologies without significant safety concerns. Preclinical studies have been performed in small animals without safety concerns.
The risks and side effects of the proposed study procedures are:
- Blood samples: drawing blood may cause slight pain and occasionally bruising
- Vaccinations: Common side effects are some mild redness and swelling at the injection site. You may feel like you have flu-like symptoms within 24 hours of the vaccinations. These usually resolve within 48 hours.
Please refer to the information sheet for full details of procedures and potential risks.
What will happen if I don’t want to carry on with the study?
Participation is voluntary and you are free to change your mind and withdraw at any time. You do not need to provide a reason. This will not affect your subsequent medical care in any way. If you withdraw we might need to offer you a follow up visit, for example to check the vaccination site or a blood result.