Leiden, The Netherlands / Rockville, MD, USA (September 22, 2010) Dutch biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) and the Aeras Global TB Vaccine Foundation today announced the start of a Phase II clinical trial in infants of the jointly developed tuberculosis (TB) vaccine candidate, AERAS-402/Crucell Ad35.
The main objective of the trial is to test the safety and efficacy of the TB vaccine candidate in infants previously vaccinated with the Bacille Calmette-Gurin (BCG) vaccine, which is currently the only vaccine licensed to help prevent TB. The first part of this clinical trial, which will be conducted in Kenya, will establish the optimal dosing regimen. The selected regimen will then be tested in the second part of the trial, which is planned to begin in 2011 in Kenya, Mozambique, South Africa and Uganda.
The Phase II study of AERAS-402/Crucell Ad35 is being led in Kenya by a joint research project of the Kenya Medical Research Institute and the US Centers for Disease Control and Prevention, called the KEMRI/CDC Research and Public Health Collaboration. Participants from the Siaya District in Nyanza Province of Western Kenya will be enrolled.
"Despite the availability of the BCG vaccine, two million men, women and children die from tuberculosis every year. We urgently need a new TB vaccine to ensure long-term and effective TB protection," said Jim Connolly, President and CEO of the Aeras Global TB Vaccine Foundation. "This clinical trial represents an important step in our collaboration among a global network of researchers and the people of Kenya, who continue to be at high-risk for TB infection."
In 2004, Aeras and Crucell began jointly developing this vaccine candidate using Crucell's AdVac vaccine technology and PER.C6 manufacturing technology.
"I am extremely pleased at the pace in which our work to develop a next generation vaccine against TB is progressing. O
|Contact: Annmarie Leadman|
Aeras Global TB Vaccine Foundation