CRUCELL REPORTS SAFETY DATA ON WEST NILE VACCINE

Crucell has announced the completion of its 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 study in which three different dosages of the vaccine were tested. The study was conducted in Belgium and is the first safety study in humans with a whole-inactivated Flavivirus vaccine produced by PER.C6 technology, according to the company.

The primary endpoint of the study was the incidence of adverse events during the period of two months after the first intramuscular administration of the vaccine. The vaccine was administered twice with a three-week interval. Administration of the vaccine was systemically and locally well tolerated. Headache and local reactions at the reaction site were the most common reported adverse events across all arms.

"We are pleased with the positive Phase I safety results," Jaap Goudsmit, Crucell's chief scientific officer, said. "It is encouraging that the immune response observed in vaccines, which was the secondary objective of the study, is in line with the observations in vaccinated geese."

The veterinary vaccine for geese, which produced excellent safety data and almost 100 percent efficacy in challenge experiments, protects against the Israel 1998 goose strain of West Nile virus, which is closely related to the New York 1999 strain responsible for the outbreaks in the U.S., according to the company.