Dynavax releases results of hepatitis B vaccine phase-3 trial

Trial shows Heplisav demonstrated better protection of diabetes patients than approved vaccine

BERKELEY, Calif. — An experimental vaccine for hepatitis B made by Dynavax Technologies appears to work better in patients with diabetes than current treatments, the company said.

The company announced results of two phase-3 trials of the vaccine Heplisav, one of which was the first to prospectively evaluate the effectiveness of vaccinations with recombinant hepatitis B vaccines in patients with diabetes. Dynavax said results from that trial showed that Heplisav provided faster, more orbits and convenient, longer-lasting immunity in people with diabetes than a currently available vaccine, GlaxoSmithKline's Engerix-B.

The trial enrolled 218 adults older than 40 with diabetes, of whom 179 were given Heplisav, while 39 received Engerix-B; Dynavax said Heplisav showed better protection than Engerix-B in week 8 through week 52.

On Tuesday, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend that patients with diabetes older than 60 years be vaccinated against hepatitis B. The CDC has recommended that infants be routinely vaccinated against hepatitis B since 1991.

"Given [Tuesday's] ACIP recommendation, we believe Heplisav will, if approved, play an important role in meeting the needs of these patients," Dynavax president and chief medical officer Tyler Martin said. "In addition, Dynavax has demonstrated similar advantages in other hard-to-immunize populations, including males, smokers and obese subjects."


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