The first test of Aeras’s MVA85A TB
vaccine has shown it to be ineffective in preventing new infections in infants
and in stopping the progression of existing infections. The researchers studied
2,800 South African infants in the rural outskirts of Cape Town. The
researchers immunized 2,797 infants aged 4 months. All infants received BCG
vaccines; half then received MVA854A and half received a placebo. In the
vaccine group, 13 percent became infected with the TB bacterium and 2 percent
developed active disease; in the placebo group, 12 percent became infected and
3 percent developed active disease. These differences were not statistically
significant.
In the vaccine group, 80 percent had
at least one “systemic” side effect, as did 76 percent in the placebo group.
Also, 18 percent of the children in each group had a serious adverse event, and
seven from the vaccine group and four from the placebo group died during the
study. None of the problems were believed to result from the vaccine.
Tom Evans, Aeras’s chief scientific
officer, commented that the company is disappointed that the trial did not have
a positive outcome, but it does not mean that this type of vaccine would not be
useful in another population.
The study, “Safety and Efficacy of
MVA85A, a New Tuberculosis Vaccine, in Infants Previously Vaccinated with BCG:
A Randomised, Placebo-Controlled Phase 2b Trial,” was published online in the
journal The Lancet (2013; doi:10.1016/S0140-6736(13)60177-4).
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