NanoBio Hepatitis B Vaccine Program:

A $6.3-million Grand Challenges grant to The University of Michigan Nanotechnology Institute for Medical and Biomedical Sciences (M-NIMBS) supports development and testing of a NanoStat nanoemulsion-based Hepatitis B vaccine that uses two nasal administrations rather than injections.  Needle free administration makes treatment by by non-medical personnel possible and eliminates the potential for disease transmission via accidental needle sticks.  The heat-stable vaccine also avoids the requirement for vaccine refrigeration, which often is unavailable in developing countries.

We have demonstrated that mucosal vaccination provided serum antibody titers equivalent to standard alum-based hepatitis B vaccines as well as a strong TH1 cellular immune response in mice. 

Many of the safety studies, stability data and manufacturing scale up activities included in this program are supportive of the development of additional NanoStat platform mucosal vaccines.  NanoBio owns rights to all intellectual property related to the product and will direct further development after the clinical proof-of-concept is completed by M-NIMBS. 

About Hepatitis B:

Hepatitis B is a serious disease caused by a virus that attacks the liver.  The virus, which is called hepatitis B virus (HBV), can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death.  The risk of death from HBV-related liver cancer or cirrhosis is approximately 25% for persons who become chronically infected during childhood.

The World Health Organization reports that in much of the developing world, (sub-Saharan Africa, most of Asia, and the Pacific), most people become infected with HBV during childhood, and 8% to 10% of people in the general population become chronically infected.  In these regions liver cancer caused by HBV is among the first three causes of death by cancer in men.

High rates of chronic HBV infection are also found in the Amazon and the southern parts of Eastern and Central Europe.  In the Middle East and Indian sub-continent, about 5% are chronically infected.  Infection is less common in Western Europe and North America, where less than 1% are chronically infected.  It is estimated that there are 1.25 million chronically infected Americans, of whom 20-30% acquired their infection in childhood.