Crucell's PER.C6-based West Nile Vaccine good in trials

Dutch biotechnology company Crucell NV has completed a Phase I safety study with the alum adjuvanted formulation of its whole inactivated West Nile vaccine manufactured using PER.C6 technology.

A total of 47 subjects were enrolled into the randomized, double-blind, placebo-controlled, dose-escalation trial in which three different dosages of the vaccine were tested. This was conducted in Belgium and is the first safety study in man with a whole inactivated Flavivirus vaccine produced by PER.C6 technology.

The primary endpoint was the incidence of adverse events during the period of two months after the first intra-muscular administration of the vaccine, which was given twice with a three weeks interval. Administration of the vaccine was systemically and locally well tolerated. Headache and local reactions at the injection site were the most common reported adverse events across all arms.