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Aeras, Crucell and South African Tuberculosis Vaccine Initiative Announce Encouraging Preliminary Results of Tuberculosis Vaccine Clinical Trial in South Africa
Date:4/9/2008

ATLANTA, April 9, 2008 /PRNewswire-USNewswire/ -- Dutch biotechnology company Crucell N.V., the Aeras Global TB Vaccine Foundation and the South African Tuberculosis Vaccine Initiative (SATVI) present a progress update and immunology data from a Phase I Ad35 tuberculosis vaccine study at the biennial "Tuberculosis Vaccines for the World" conference (Atlanta, Georgia, April 9 to 11) today. The study, conducted in Worcester, South Africa and launched in May 2007, is the second phase I study in a current series of three and has revealed promising results.

Highest CD8 immune responses ever in a TB vaccine study

Preliminary data show both critical arms of the cellular immune system, CD4 and CD8 immune T-cells were induced and that in those participants who responded, CD8 immune responses are considerably higher than has ever previously been seen in a TB vaccine study.

The trial of AERAS-402/Crucell Ad35, which began in May 2007, is being conducted as a double-blind, randomized, placebo-controlled dose escalation study in four groups of healthy adults vaccinated at birth with BCG (Bacille Calmette-Guerin) vaccine. A total of 40 healthy adult volunteers are enrolled.

"While preliminary, these results are promising. We are pleased that Crucell's technologies are playing a key role in the search and development of a much-needed TB vaccine," said Dr. Jaap Goudsmit, Chief Scientific Officer at Crucell. "We highly value the collaboration with Aeras and SATVI on this important mission."

Third key clinical phase I study in progress

Aeras and Crucell began jointly developing this vaccine candidate in 2004 using Crucell's AdVac(R) vaccine technology and PER.C6(R) manufacturing technology. A first Phase I clinical trial launched in October 2006 in Kansas, USA indicated that the vaccine candidate is safe in healthy adults in the US. The results of a second study, launched in May 2007, are presented in Atlanta at the "TB
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SOURCE Aeras Global TB Vaccine Foundation
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