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Crucell and AERAS Announce Start of Tuberculosis Vaccine Clinical Trial

27 Oct 2006 - Crucell N.V. announced that it has started the phase I clinical trial of the AdVac®-based tuberculosis vaccine it is developing in partnership with The AERAS Global TB Vaccine Foundation. The clinical trial will be an open-label study that will test the vaccine in a dose-escalation trial involving 24 healthy volunteers. The Phase I trial will be funded and managed by Aeras through a Contract Research Organization (CRO), PRA Clinical Pharmacology Center in Lenexa, Kansas, USA. The main parameters under examination will be safety, tolerability and immunogenicity.
 
According to the company, 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. The production scale potential of the PER.C6® cell line has been demonstrated in an unprecedented successful bioreactor run of 20,000 liters. Such highly productive systems are particularly important in the case of poverty-related diseases such as HIV, malaria and TB, when 10-100 millions of doses need to be manufactured while keeping costs relatively low.