New Hep B vaccine trial sees patient diagnosed with Wegener's granulomatosis

[carriebft]

http://www.reuters.com/article/gover...23616020090209

The FDA has since halted the trial:

The U.S. Food and Drug Administration, which placed a clinical hold on the drug in March, asked for additional clinical and safety information to help with risk assessment.

Heplisav was placed on hold -- an FDA order to delay or halt trials -- after a patient receiving the vaccine was preliminarily diagnosed with Wegener's granulomatosis, a disease in which blood vessels get inflamed.

The drug had been in late-stage trials as a treatment for both otherwise-healthy adults and for patients with end-stage renal failure.