Crucell and Aeras initiate Phase I tuberculosis vaccine trial in infants

Netherlands-based biopharmaceutical company Crucell and the Aeras Global TB Vaccine Foundation have initiated a Phase I clinical trial in infants of the jointly developed tuberculosis vaccine candidate, AERAS-402/Crucell Ad35. This is believed to be the first clinical trial designed to test this vaccine candidate in infants.

The Phase I study of AERAS-402/Crucell Ad35 will be conducted by the South African Tuberculosis Vaccine Initiative (SATVI) in the Western Cape region of South Africa.

The main objective of the study will be to test the safety of the tuberculosis (TB) vaccine candidate in infants previously vaccinated with the Bacille Calmette-Guerin vaccine, which is currently the only vaccine licensed to help prevent TB.

The AERAS-402/Crucell Ad35 vaccine candidate has previously been tested for safety in healthy adults in the US and South Africa, and adults exposed to TB in South Africa and Kenya. Approximately 54 healthy infants who have not been exposed to TB or HIV will be enrolled in the study.

Jaap Goudsmit, chief scientific officer of Crucell, said: We are very pleased that the collaboration with Aeras and SATVI enables us to enter into this new trial. Using Crucell’s technologies, we are on a joint mission to develop a new vaccine against TB that could increase the number of people protected from infectious diseases worldwide.