CRUCELL, NIH TO BEGIN MALARIA VACCINE STUDY

Crucell announced it has obtained regulatory approval to test the safety, tolerability and immunogenicity of its AdVac-based malaria vaccine it is currently developing in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. This opens the door for starting a Phase I clinical trial.

The trial will be a randomized, double-blind, placebo-controlled study that will test the vaccine in a dose-escalation trial involving 96 healthy volunteers. The Phase I trial will be funded by NIAID and conducted by researchers at Vanderbilt University, one of NIAID's Vaccine and Treatment Evaluation Units.

In 2004 Crucell announced that NIAID would support the development of an AdVac-based candidate malaria vaccine. The agreement has an estimated value of up to $3.5 million. In September Crucell and NIAID extended the collaboration with the signing of a clinical trial agreement.

AdVac is a vaccine technology developed by Crucell considered to play a potentially important role in the fight against emerging and reemerging infectious diseases, and in biodefense, according to the company. The technology supports the practice of inserting genetic material from the disease-causing virus or parasite into a vector, which then delivers the immunogenic material directly to the immune system. Most vectors are based on an adenovirus, such as the virus that causes the common cold.