CRUCELL, AERAS FOUNDATION BEGIN TB VACCINE CLINICAL TRIAL

Dutch biotechnology company Crucell announced it has started a clinical trial of the AdVac-based tuberculosis (TB) vaccine it is developing in partnership with the Aeras Global TB Vaccine Foundation. The Phase I trial will be an open-label, dose-escalation study that will test the vaccine in healthy volunteers. The main parameters under examination will be safety, tolerability and immunogenicity.

The second-generation Ad35 vector applied in the Crucell-Aeras TB program is extremely suitable for vaccine production on PER.C6 cell culture at scale. Crucell's PER.C6 technology is a cell line developed for the large-scale manufacture of biopharmaceutical products including vaccines. Such highly productive systems are particularly important in the case of diseases such as HIV, malaria and TB, where millions of doses need to be manufactured while keeping costs relatively low for use in developing countries.

Tuberculosis is the world's second deadliest infectious disease behind HIV, with 8 to 9 million new cases diagnosed each year, according to the World Health Organization. Nearly 2 million people die from TB each year. The current TB vaccine is more than 80 years old and has limited effect during childhood and offers no protection against TB for adolescents and adults, Crucell says.

AdVac is a vaccine technology developed by Crucell that 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. AdVac technology is specifically designed to manage the problem of preexisting immunity in humans against the most commonly used recombinant vaccine vector, adenovirus serotype 5 (Ad5), without compromising large-scale production capabilities or the immunogenic properties of Ad5.