22 September 2010 - Leiden, The Netherlands / Rockville, MD, USA - Dutch biopharmaceutical company Crucell N.V. 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-Guérin (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 jointly in Kenya by the Kenya Medical Research Institute and the US Centers for Disease Control and Prevention. Participants from the Siaya District in Nyanza Province of Western Kenya will be enrolled.
AERAS-402/Crucell Ad35 has been tested in seven early-stage clinical trials including a phase I clinical trial in infants in South Africa. A Phase II trial to test its safety and efficacy in adults living with HIV is ongoing in South Africa. To date, the candidate has been shown to have an acceptable safety profile in these populations.