Tuberculosis (TB) treatment is long-term and complicated, lasting up to two years, and there are high levels of multidrug resistance. Immune Network is trying a different approach--a once-daily oral tuberculosis vaccine, and Immunitor, the vaccine's developer, announced Phase II results at the Drug Resistance and Persistence in Tuberculosis meeting in Uganda, part of the Keystone Symposia Global Health Series.
In the study, carried out in the Ukraine, people with tuberculosis were given the oral vaccine, known as V7. This is an oral tablet formulation of heat-killed Mycobacterium vaccae, and is given alongside TB drugs. The patients included those with recurring TB, with multi-drug resistant (MDR-TB) and TB with HIV co-infection.
After just one month, almost 80% of the patients receiving the vaccine showed no M. vaccae in their sputum smears, compared with just under 20% of those dosed with a placebo. There was no apparent difference between the groups, whether drug-resistant, non-drug-resistant, treatment-failed or co-infected with HIV.
"Remarkable anti-TB activity resulting from daily dosing with oral M. vaccae supports [the] earlier study in Argentina, which has been conducted in drug-sensitive TB patients. Our results indicate that conventional TB therapy can be shortened significantly and further investigation in a larger population is needed," said Dr. Dmytro Butov, the principal investigator in the study.
Immune Network acquired Immunitor's oral vaccine technology in 2010. The vaccine is based on a preparation already sold in China as an adjunct immunotherapy for TB, and could provide a low-cost addition to TB therapy, shortening the course of treatment. This is important as long courses of treatment are hard to stick to, and stopping drugs early increases the chance of patients developing drug-resistant forms of the disease.
- read the press release