The clinical trial will test the vaccine in a dose-escalation trial involving 24 healthy volunteers. The main parameters under examination will be safety, tolerability and immunogenicity.
“The start of this phase I trial is important to our overall goal of developing a new vaccine to help eliminate the current TB pandemic,” added Dr Jerald Sadoff, CEO of Aeras.
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. 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.