There is an urgent need for a more effective tuberculosis vaccine than the standard BCG vaccine.A phase III trial showed that the investigational VPM1002 vaccine was not more effective at preventing tuberculosis infection compared with the BCG vaccine in newborns.With fewer QFT conversions overall than predicted (344 vs 632), the investigators terminated the trial early.
An investigational tuberculosis (TB) vaccine didn't top the standard bacillus Calmette-Guérin (BCG) vaccine at preventing infections in infants, a multicenter, phase III trial showed.
Among nearly 6,900 newborns in sub-Saharan Africa, QuantiFERON-TB Gold Plus (QFT) conversion, indicating Mycobacterium tuberculosis infection or exposure, occurred in 5.3% of those who received the VPM1002 vaccine compared with 4.3% of those who received the BCG vaccine, reported Sina Brückner, PhD, of Serum Life Science Europe in Hanover, Germany, and colleagues in Lancet Infectious Diseases.
For events meeting the first-case definition for QFT conversion in the VPM1002 group versus the BCG group, the HR was 1.23 (95% CI 0.99-1.53, P=0.057). Noninferiority required the upper bound of the confidence interval to be less than 1.25.
The trial also delivered uncertainty about VPM1002's relative efficacy at preventing TB disease. Among 588 participants evaluated for suspected TB disease during follow-up, 3.2% of those who received VPM1002 and 1.7% of those in the BCG group developed microbiologically confirmed or unconfirmed TB.
