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news.Crucell has reported that it will receive up to $5 million from Aeras Global TB Vaccine Foundation to support the advanced development of its AdVac-and PER.C6-based tuberculosis vaccine.
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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 US, indicates that the vaccine candidate is safe in healthy adults in the US. A second study in progress in healthy adults in South Africa appears to be showing safety, tolerability and immunogenicity of AERAS-402.
Crucell and Aeras have also announced the launch of a new Phase I BCG-Ad35 prime boost clinical trial of the unique AdVac-based tuberculosis vaccine. The trial will be conducted in St. Louis, Missouri, US at the Saint Louis University Center for Vaccine Development.
The main parameters under examination in the study will be the immunogenicity and safety of BCG prime followed by two AERAS-402 boost doses administered at three to six month intervals after BCG in healthy adults. The trial will be conducted as double-blind, randomized, placebo-controlled study in 32 healthy adult volunteers.