Hepatitis B Vaccine Study Launches for Dialysis Patients

A biopharmaceutical company announced the enrollment of the 1st of 100 patients in the company’s open-label, single-arm clinical study of HEPLISAV-B in adults with end-stage renal disease who are initiating or undergoing hemodialysis. 

There is no cure for hepatitis B, but effective vaccination can prevent the disease. 

The primary endpoints of this phase 1 study, NCT03934736, are to evaluate the immunogenicity induced by HEPLISAV-B at week 20, as measured by seroprotection rate and to evaluate the safety of HEPLISAV-B with respect to clinically significant adverse events. 

This time frame is important since Hepatitis B has a long incubation period. 

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like receptor (TLR), 9 agonist, to enhance the immune response.

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. The hepatitis B virus is 50 to 100 times more infectious than HIV, and transmission is on the rise. 

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. 

Additionally, the U.S. Preventive Services Task Force has issued a recommendation which reaffirms there is ‘convincing evidence that screening for hepatitis B virus (HBV) infection in pregnant women to avoid transmitting the disease to their future children.’   

“Although vaccination to prevent hepatitis B infection has been standard practice for decades for dialysis patients, there remains a need to provide improved overall protection safely through a greater and more durable antibody response,” said Robert Janssen, M.D., chief medical officer of Dynavax. 

“We’re hopeful that this patient population may benefit from this new and shortened dosing schedule as compared to currently approved treatments.” 

The Centers for Disease Control and Prevention (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas. 

Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion. 

About 1.2 million people in the United States are infected with hepatitis B, says the CDC. 

Hepatitis B tests can be ordered online from UltaLabs.

For more information, visit HEPLISAV-B.