An initiative has been announced by NanoBio Corporation to develop an intranasal vaccine for the treatment of hepatitis B.
The potential vaccine will be developed by NanoBio and the University of Michigan's Michigan Nanotechnology Institute for Medicine and Biological Sciences through funding received from the National Institutes of Health.
Hepatitis B, an infection of the liver caused by the HBV virus, is the most common cause of chronic viral liver disease worldwide.
Hepatitis B has chronically infected more than 370 million people and causes nearly one million deaths annually as a result of cirrhosis and liver failure.
HBV is transferred via bodily fluids and blood, commonly through sexual intercourse and intravenous drug use.
Vaccinations for HBV are commonly given to infants to prevent infection, which has contributed to lower rates of HBV incidence in recent years. For patients previously infected, recurring infection cannot be mitigated with existing vaccines.
"Currently available HBV vaccines are effective prophylactics, but lack therapeutic properties for those that are already infected," James R. Baker, MD, CEO and founder of NanoBio, said. "This new intranasal vaccine would have great value as a treatment to reduce the risk of HBV associated liver diseases and deaths globally. The vaccine is also highly stable at room temperature enabling storage without refrigeration, a factor of great importance in the developing world."
NanoBio and teams from the University of Michigan plan to demonstrate the capabilities of a nanoemulsion-based HBV vaccine in animals as a means of safely inducing immune responses in the presence of confounding factors including kidney failure. Individuals with kidney function deficiencies are at a high risk for complications of HBV infection compared to normal individuals.
NanoBio, following successful completion of the preclinical studies that will be funded by this STTR, plans to conduct an FDA-approved Phase 1 clinical trial to evaluate safety, dose range, immunogenicity and preliminary efficacy against chronic HBV in humans with kidney failure.