October 20, 2008

Crucell and Aeras Initiate Phase I Tuberculosis Vaccine Trial in Kenya

Dutch biopharma company Crucell and the Aeras Global TB Vaccine Foundation have started a Phase I clinical trial in Kenya of the jointly developed tuberculosis vaccine candidate, AERAS-402/Crucell Ad35.

This study of the new tuberculosis (TB) vaccine candidate in Kenya will be conducted by the Walter Reed Project-Kenya (WRP) at Kombewa, near Kisumu, western Kenya.

The main parameters of the study will be to test the safety of the candidate in healthy adults, all of whom have been previously vaccinated with the Bacille Calmette-Guerin vaccine and a subset of whom have evidence of having been exposed to TB.

Crucell and Aeras also announced the start of the first Phase II study of AERAS-402/Crucell Ad35. The study is being conducted in Cape Town, South Africa by the University of Cape Town Lung Institute in conjunction with the South African Tuberculosis Vaccine Institute. Screening of volunteers has begun and immunization is scheduled to start in the next couple of weeks. The candidate will be tested in 82 adults who have had active TB.

Jaap Goudsmit, Crucell's chief scientific officer, said: "We are very pleased with our continued progress with this next generation TB vaccine. The initiation of these two new studies through our fruitful collaboration with Aeras puts us another step closer to our ambition of reducing the global burden of this fatal disease."