Clinical trial reveals promising tuberculosis vaccine candidate

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A 3-year clinical trial conducted in tuberculosis (TB) -endemic regions has reported the effects of a TB candidate vaccine. The trial, recently published in New England Journal of Medicine, revealed that the M72/AS01E vaccine is 54% effective at preventing active pulmonary TB in TB-infected adults.

The trial, done in partnership with IAVI (NY, USA), was conducted in Kenya, South Africa and Zambia and involved a cohort of 3573 HIV-negative adults. One group of participants were given a placebo and another were given two doses of the vaccine, administered 1 month apart.

Throughout the 3 years of the trial, signs of active pulmonary TB disease were monitored in the participants. A range of surveillance techniques were used, including visits, telephone calls and patient reports. Participants suspected of having the disease were formally diagnosed by a polymerase-chain-reaction test or mycobacterial culture.

In the placebo group, 26 cases of disease occurred, whereas in the vaccine- group there were 13 cases. The incidence in the vaccine group were found to be significantly lower than the placebo group, demonstrating that the vaccine was effective at protecting the adults against active pulmonary TB.

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