Phase II clinical trial of tuberculosis vaccine candidate to begin next month in South Africa

The Areas Global TB Vaccine Foundation next month will begin a Phase II clinical trial of a new tuberculosis vaccine candidate that aims to improve on the existing BCG vaccine, Bloomberg reports.

Areas, which is supported by the Bill & Melinda Gates Foundation, is developing the vaccine candidate in partnership with the Oxford-Emergent Tuberculosis Consortium. The study, which is a collaborative effort with the South African Tuberculosis Vaccine Initiative, is expected to cost $14 million and will be funded by Areas and the Wellcome Trust, according to Bloomberg.

The trial will involve 2,800 infants in South Africa, according to Jerald Sadoff, head of Areas. Researchers will begin recruiting infants early next month to participate in the trial at the Brewelskloff TB Hospital in Worcester, South Africa. All of the infants will receive the BCG vaccine at birth, and half will receive the experimental vaccine at age 18 weeks, with the other half receiving a placebo at 18 weeks. The study aims to show at least a 60% reduction in pulmonary TB among children who receive the experimental vaccine, compared with those who receive the placebo. Initial results could be available by 2011 or 2012, Helen McShane, an HIV physician and researcher at Oxford who developed the vaccine, said.

"This is the first of new-generation TB vaccines to go into this kind of study looking at efficacy in infants," McShane said, adding, "It's enormously exciting, and I sincerely hope we will see some efficacy." Sadoff added, "A vaccine is absolutely essential if we are going to get this [TB] epidemic under control" (Matsuyama/Gale, Bloomberg, 3/23).