Crucell, AERAS and SATVI Announce Start of Tuberculosis Vaccine Clinical Trial in South Africa
Crucell N.V., the Aeras Global TB Vaccine Foundation and the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town announced the launch of a new Phase I clinical trial of the unique AdVac®-based tuberculosis vaccine, six months after launching a similar study in the US. 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.
Aeras and Crucell began jointly developing this vaccine candidate, called AERAS-402, in 2004 using Crucell's AdVac® vaccine technology and PER.C6® manufacturing technology. A Phase I clinical trial launched in October 2006 in the United States 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 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 (BCG). A total of 30 healthy adult volunteers will be enrolled.
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