Clinical trials of new tuberculosis vaccine started

Based on an article published in the December issue of Lancet, it is possible that the BCG vaccine, which has existed for 80 years, will soon be replaced by the new MVA85A vaccine, which will be used jointly with the BCG vaccine.

The six-year study began in Oxford and will continue to be carried out in parallel in countries where TB is endemic. The project manager is Dr. Helen McShane of the John Radcliffe Oxford Clinic.

WHO estimates that if no further action is taken to combat tuberculosis, the disease will kill at least 35 million lives worldwide over the next two decades.

The new MVA85A vaccine, made in Germany, has already passed the first phase of clinical trials assessing its safety and immunogenicity in healthy volunteers.

The researchers evaluated three options for using TB vaccines: the first is BCG without MVA85A (the degree of immune response has been assessed); the second is MVA85A without BCG (the degree of immune response and safety have been assessed); the third is a BCG vaccine followed by the introduction of MVA85A.

In each study design, 12 healthy volunteers who did not suffer from tuberculosis participated.

A clinically important result in this study was an immunological evaluation of the effectiveness of vaccination.

Systematic vaccination of schoolchildren in Oxford with the BCG vaccine was completed in 1981, when there was a significant decrease in the incidence of tuberculosis.

According to Dr McShane, as soon as the safety and immunogenicity data of the new MVA85A vaccine become available, parallel studies will be possible in tuberculosis endemic areas, for example in Africa.

People infected with HIV are more likely to develop drug-resistant forms of tuberculosis, and a well-developed strategy is urgently needed in Africa to combat both tuberculosis and HIV infection.