FRIDAY, JUNE 22, 2018

Dynavax's two Phase III hepatitis vaccine trials obtains DSMB clearance

Officials with Dynavax Technologies recently announced the second of its planned safety assessments have been completed for Phase III trials of Heplisav, a vaccine designed to protect against hepatitis B., according to a report.

The Data Safety Monitoring Board, Dynavax officials said, performed the safety assessments. The assessments included data from 2,264 test subjects who received their first injection. Of those, 1,611 have received a first and second injection.

Dynavax officials said the DSMB determined that the studies may continue without modification, according to the report.

The DSMB is an independent group of medical experts that evaluate and review subject safety data at regular intervals throughout the ongoing clinical trials.

Hepatitis B is caused by infection with the Hepatitis B virus. The incubation period from the time of exposure to onset of symptoms is six weeks to six months. HBV is found in highest concentrations in blood and in lower concentrations in other body fluids. HBV infection can be self-limited or chronic.

In adults, approximately half of newly acquired HBV infections are symptomatic, and approximately one percent of reported cases result in acute liver failure and death. Risk for chronic infection is inversely related to age at infection.

Approximately 90 percent of infected infants and 30 percent of infected children aged five years become chronically infected, compared with two to six percent of adults, according to the Centers for Disease Control.