Hepatitis B is the world’s most common liver infection and can lead to cirrhosis and liver cancer. The virus is transmitted through blood contact, unprotected sex, re-used needles or delivery of a new born from an infected mother. Although a proportion of adults are able to rid of the virus without any problem, a number develop chronic infections, as do most infected babies and children. According to the World Health Organisation (WHO) fact sheet, two billion people in the world have been infected with the virus, and 350 million people are chronic carriers. Approximately one million people in the world die from liver failure each year. Because of the severity of Hepatitis B, the WHO called in 1991 for all the countries to add Hepatitis B vaccines to their national immunisation programs. Vaxine has developed a novel Hepatitis B vaccine that combines Advax™ adjuvant with a novel hepatitis B vaccine antigen. This vaccine showed marked enhancement of both B- and T-cell responses to HBV in animal models and in early human clinical trials enhanced antibody and T-cell responses against HBV. In 2007, Thomson Scientific ranked Vaxine's prophylactic HBV vaccine as one of the top 5 products in the world entering Phase 2 clinical testing. Approval has recently been received to conduct a trial of this vaccine for HBV immunisation of subjects with immune impairment due to diabetes, kidney failure or older age.
To target unmet medical needs, Vaxine is also developing a therapeutic HBV vaccine. There is currently no cure for chronic HBV infection with interferon-alpha and antiviral drugs normalising liver enzyme function in 40-70% of patients but not eradicating the virus. These drugs are costly and cause significant side-effects. In addition, viral mutations lead to drug resistance thereby diminishing the effectiveness of these strategies. To meet the need for innovative and more effective treatments to fight against chronic HBV infection Vaxine has been testing therapeutic HBV vaccine candidates with plans to commence a human phase I therapeutic vaccine trial in 2016.