Note: Development discontinued

It has been decided that these programs will no longer be continued. Crucell has come to the conclusion that the commercial and market opportunities for its West Nile products are not as attractive as other products in Crucell's pipeline.
Fast Facts
  • Crucell was developing a vaccine to prevent West Nile virus in humans, based on an inactivated (‘killed’) whole virus and produced on Crucell’s PER.C6® technology.
  • An agreement with the Netherlands Vaccine Institute (NVI) allows manufacture of the vaccine at the NVI new BioSafety Level 3 plant for use in clinical trials.
  • Phase I clinical trials were completed at the beginning of 2007, demonstrating safety and tolerability.
  • Crucell also developed human monoclonal antibodies for therapeutic use against West Nile.

 

 Description

Crucell’s West Nile virus vaccine uses an inactivated whole virus approach, growing the virus on PER.C6® cells and then inactivating it for application in a vaccine.

 

In a separate but related program, Crucell has collaborated with Israeli Kimron Veterinary Institute in the development of an inactivated whole-virus vaccine for veterinary use. Market authorization was granted in June 2004.

 

 Development Rationale

Currently there is no vaccine or antiviral therapy available to protect humans against West Nile virus. Crucell has decided to develop a vaccine, based on the company's PER.C6® technology, in an effort to address this important unmet medical need. Crucell's PER.C6® technology has been shown to support the efficient production of a vaccine against West Nile virus.

Development Status

Human Vaccine

Crucell has concluded preclinical studies in a goose animal model with its experimental West Nile virus vaccine. The results of these preclinical studies, demonstrating that a PER.C6®-based vaccine protects against the Israel 1998 goose strain of West Nile virus, were used to obtain market authorization in Israel for a veterinary West Nile vaccine and have provided the proof of concept for the human West Nile vaccine.

 

An agreement with The Netherlands Vaccine Institute (NVI) was announced in November 2004 for the manufacture of the West Nile vaccine at NVI’s new BioSafety Level 3 plant for use in the human clinical trials.

 

Crucell’s WNV vaccine has completed a Phase I, double-blind, placebo-controlled study of 48 healthy volunteers, demonstrating safety and tolerability.  The results were announced on 26 January 2007. Phase II studies are currently being planned.

 

Veterinary Vaccine

In June 2003, Israeli Kimron Veterinary Institute signed a license agreement with Crucell to use Crucell's PER.C6® cell line technology to develop a veterinary West Nile virus vaccine for geese. Following successful safety and efficacy trials, market authorization for Israel was granted in June 2004. Kimron has announced that it intends to replace its existing West Nile veterinary vaccine, which is produced using mouse brain cells, with the PER.C6®-based vaccine.
About West Nile Virus

Named after the West Nile district of Uganda where the disease was discovered in 1937, West Nile virus infection can lead to mortality in humans and animals by causing a fatal form of encephalitis, or inflammation of the brain. It is estimated that 20% of the people who become infected with West Nile virus will develop West Nile fever. Persons over 50 years of age have the highest risk of developing a severe disease, such as meningitis, an inflammation of the membrane around the brain and the spinal cord, or encephalitis, an inflammation of the brain. Since 1999, West Nile virus has caused disease in more than 16,000 U.S. citizens, leading to 650 deaths.

 

Continued efforts are being made to find suitable treatments and vaccines to stop this virus. The virus may become a recurring threat in the United States. In 2003 and 2004, a number of West Nile virus cases were reported in Europe.