Behringwerke's TBE Vaccine - Phase III

Behringwerke of Germany has reported tolerance and immunogenicity data from a Phase III study of its new inactivated tick-borne encephalitis (TBE) vaccine.

A total of 1,018 subjects were vaccinated with the vaccine using either a long schedule (three doses over one year) or a short schedule (three doses over three weeks). A reduced dose schedule was also assessed in children. The vaccine induced high levels of TBE antibodies in both schedules (98.7% in children and 96.9% in adults on day 42). No subject contracted TBE over a four-year follow-up period. The vaccine was well-tolerated, with fever the most common reaction (more common in children than adults), followed by headache, injection site pain and asthenia. Most of the reactions were reported only after the first vaccination.

The data from the subsequent persistency observation study indicate that a first booster vaccination should be given at one year, with subsequent boosters given after three to five years, note the researchers.