Crucell, AERAS and SATVI Announce Start of Tuberculosis Vaccine Clinical Trial in South Africa
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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