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Crucell N.V.
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Publicatie datum
09 apr 2008 - 14:08
Statutaire naam
Crucell N.V.
Titel
Aeras, Crucell and SATVI Announce Encouraging Preliminary Results of Tuberculosis Vaccine Clinical Trial in South Africa
Bericht
Atlanta, Georgia, USA / Leiden, The Netherlands, 9 April 2008 - 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 Worchester, 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-Guérin) 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® vaccine technology and PER.C6® 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 Vaccines for the World’ conference. A thir
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