|Mycobacterium tuberculosis--Courtesy of NIAID|
With multidrug-resistant forms of tuberculosis on the rise, and the variable efficacy of the generic BCG vaccine, it is getting harder and harder to treat the disease. The Infectious Disease Research Institute (IDRI) is stepping up to the plate and taking its TB candidate to Phase IIa trials in South Africa.
The trial, funded by a Wellcome Trust grant of $5.8 million, will assess the candidate's ability to reduce TB recurrence following treatment, IDRI said in a statement. Because Mycobacterium tuberculosis can lie dormant in the body, TB disease may recur after having successfully receiving anti-tuberculosis treatments. While those with latent tuberculosis are neither symptomatic nor infectious, those with active TB disease are both, which can undermine efforts to control the spread of the disease.
"The Phase IIa trial will be the first dose-escalating TB vaccine trial conducted in persons who have previously had active TB and been successfully treated with a full course of antibiotic therapy," said Rhea Coler, vice president of preclinical development for IDRI, in the statement. "This is an important study population as the incidence of TB can be higher in people recently cured of the disease."
Phase I trials were conducted in the U.S. and South Africa. The former involved 60 healthy adults with no prior exposure to TB and the latter involved 66 adults who had received the BCG vaccine. Both studies showed that the candidate boosted immune response, which may protect against recurrence, the statement said. The vaccine could be used to prevent TB infection and as a post-exposure vaccine.
Previous funding for the candidate, ID93, has come from a variety of sources, including an $11.9 million grant from the NIAID.
"TB is one of the most widespread, persistent and deadly global health problems in the world today," said Steve Reed, IDRI's founder, president and chief scientific officer, in the statement. "We are very pleased to partner with the Wellcome Trust on this study to prevent disease recurrence, a particularly important issue with TB. And as we move this vaccine candidate along in development, we are at the same time transferring production technology to South Africa, where we can support development of Africa's biotechnology industry and manufacture products where they are needed most."
- here's the release