Sci-B-Vac® is a licensed, third-generation hepatitis B vaccine that has demonstrated safety and efficacy in over 500,000 patients. Sci-B-Vac® is currently approved for use in Israel and 14 other countries. In December 2017, VBI initiated patient dosing in a global, 15-month Phase 3 clinical program that, if successful, will allow the company to seek marketing authorization in the U.S., Europe, and Canada.
- Mimics all three surface antigens of the hepatitis B virus (“HBV”)
- Offers high levels of anti-HBV antibodies
- Offers rapid onset of protection
- Can be administered at lower doses than competing hepatitis B vaccines
- Free of next-generation adjuvants
Second-Generation Hepatitis B Vaccine
About Hepatitis B
Chronic Hepatitis B Infection
Hepatitis B is usually spread when blood, semen, or other body fluids from an HBV-infected person enter the body of someone who is not infected. HBV attacks the liver, causing both acute and chronic disease.
In its early stages, chronic hepatitis B infection is largely asymptomatic and many patients who may benefit from treatment go undiagnosed. Research has shown that treatment can have a major preventive effect on liver-related mortality and morbidity in persons with chronic hepatitis B infection. Efforts are needed to detect those infected who would benefit from treatment, so that the costly long-term side effects of hepatitis B can be better managed.
According to the World Health Organization (“WHO”), globally, 240 million people are chronically infected with HBV and more than 780,000 people die every year due to complications related to hepatitis B, including cirrhosis and liver cancer. In sub-Saharan Africa and East Asia, 5-10% of the adult population suffers from chronic hepatitis B infection. High rates of chronic infections are also found in central and eastern Europe, the Middle East, and the Indian subcontinent.
First and Second-Generation Hepatitis B Vaccines
First-generation plasma-derived hepatitis B vaccines were developed in the U.S. and France in the late 1970s. In the mid-1980s, second-generation recombinant DNA-based hepatitis B vaccines were constructed using yeasts transfected with DNA sequences coding for the HBV S antigen. These second-generation vaccines are currently used for universal vaccination efforts in many countries worldwide.
Sci-B-Vac®: A Third-Generation HBV Vaccine
In contrast to second-generation hepatitis B vaccines, which contain only one surface antigen (the S antigen), Sci-B-Vac® contains the S antigen and the pre-S1 and pre-S2 surface antigens. The composition of Sci-B-Vac® may provides more opportunities for the immune system to respond with antibodies that can recognize one or more components of the hepatitis B virus.