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news.Dutch biotechnology company Crucell has launched a new phase I clinical trial of an AdVac-based tuberculosis vaccine, six months after launching a similar study in the US.
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The trial will be conducted in the Boland-Overberg region of Western Cape Province in South Africa, which has one of the world’s highest TB burdens. The study is in collaboration with the Aeras Global TB Vaccine Foundation and the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town.
Aeras and Crucell began jointly developing the vaccine candidate in 2004 using Crucell’s AdVac vaccine technology and PER.C6 manufacturing technology. A phase I clinical trial launched in October 2006 in the US indicates that the vaccine candidate is safe in healthy adults in the US. The main parameters under examination in the current study will be safety, tolerability and immunogenicity of AERAS-402 in healthy adults in South Africa.
“The world desperately needs a new TB vaccine, and this clinical trial, in a region severely impacted by TB, is an important step in Aeras’ mission to develop these crucial vaccines,” said Dr Jerald Sadoff, president and CEO of Aeras.
The trial will be conducted as a double-blind, randomized, placebo-controlled dose escalation study in three groups of healthy adults previously vaccinated with Bacille Calmette-Guérin. A total of 30 healthy adult volunteers will be enrolled.
Tuberculosis is the world’s second deadliest infectious disease, with 8 to 9 million new cases diagnosed each year. According to the World Health Organization, an estimated 1.6 million people died from TB in 2005.