For the first time, researchers at McMaster University have fully designed, manufactured and tested Canada's first tuberculosis (TB) vaccine, which is all set to go under clinical trial.
Zhou Xing, a professor in the Department of Pathology and Molecular Medicine, led development of the vaccine, currently called AdAg85A vaccine, for the landmark 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.
While the vaccine was manufactured in the Robert E. Fitzhenry Vector Laboratory of the Institute of Molecular Medicine and Health on campus, most of the pre-clinical testing of the vaccine was undertaken at McMaster.
The phase 1 clinical trial will begin to recruit 48 healthy volunteers between 18 and 55 years of age in mid-April.
For more than 12-18 months, the researchers will evaluate the safety of the new vaccine and assess blood samples from vaccinated healthy human volunteers to determine whether the vaccine is generating a desired immune response.
A team of infectious disease physicians, vaccine manufacturing specialists, and immunologists at McMaster will conduct the trial.
The announcement of the new TB vaccine trial coincides with World TB Day on Tuesday, March 24, when health authorities and researchers around the world will be raising awareness about the need for new TB vaccines.
The 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," said Xing.
Smaill said that the vaccine, manufactured to clinical grade standards at McMaster, has passed all the testing required for its use in humans.