About the Study
What is Hepatitis B Virus?
Hepatitis B is a serious disease caused by a virus known as “HBV”. When you are exposed to HBV, it can “infect” you, or get into your blood where it travels to the liver and enters the cells. Once inside, the virus multiplies and attacks the liver cells causing hepatitis B infection. The liver can be severely damaged by hepatitis B. People with this disease often develop other liver diseases such as cirrhosis or liver cancer. Hepatitis B can also lead to liver failure and death.
What is this study about?
Unfortunately, there are limited effective treatments for hepatitis B. One way you can help protect yourself from getting this disease is by a vaccine that targets HBV to make it unable to enter the liver. Vaccines are designed to defend against a particular virus by boosting the ability of the body’s immune system defenses against that virus. The stronger your immune system defenses against HBV are, the better able you will be to protect yourself from hepatitis B.
When injected in the muscle, the study vaccine will teach the immune system how to recognize the HBV and destroy it. The injection must be repeated 1 month and 6 months later for better results. If the vaccination is successful, the level of special proteins in the blood (antibodies) that are created by the immune system to recognize HBV will increase in the blood. The person may be protected against the hepatitis B. Protection is thought to be long-lasting.
What is the purpose of the study?
The purpose of this study is to measure how well your immune system responds to an investigational Hepatitis B (HBV) vaccine compared with a vaccine that is currently approved for use in Canada for vaccination against HBV, and to measure any side effects that you may have after receiving the vaccine. Your immune response will be tested by measuring the amount of antibodies in your blood. If your HBV antibody levels rise above a certain protective level after you receive the vaccine, you may be protected against the actual virus if you are exposed to it.