McMaster University researchers are about to launch their tuberculosis (TB) vaccine clinical trial.
‘The exciting thing for McMaster is that this is translational research that has gone from the basic science where the vector has been designed here at McMaster, then manufactured here, with all the pre-clinical studies done at McMaster,’ said Dr. Fiona Smaill, a professor of medicine and chair of the Department of Pathology and Molecular Medicine.
Development of the vaccine for the trial was led by Zhou Xing, a professor in the Department of Pathology and Molecular Medicine.
The phase 1 clinical trial, which has the approval of Health Canada, will begin to recruit 48 healthy volunteers between 18 and 55 years of age in mid-April. Over 12 to 18 months researchers will evaluate the safety of the new vaccine (currently called AdAg85A vaccine) and assess blood samples from vaccinated healthy human volunteers to determine if the vaccine is generating a desired immune response. The trial will be conducted by a team of infectious disease physicians, vaccine manufacturing specialists and immunologists at McMaster.
McMaster researchers developed the new TB vaccine using a genetically modified adenovirus – a virus responsible for the common cold. After removing a small portion of the gene, they inserted part of the TB gene responsible for immunity. ‘It is natural ways of making the body use its own immune machinery,’ said Smaill.
‘Based on all pre-clinical studies carried out on animals, including mice, guinea pigs (who are very prone to TB) and cattle, this vaccine appears to be a very promising candidate vaccine,’ Xing said.
The vaccine has passed all the testing required for its use in humans. Along with regulatory approval from Ottawa, the TB vaccine trial has been approved by the research ethics board at McMaster University and Hamilton Health Sciences (HSC).
Release Date: March 24, 2009
Source: McMaster University