The study, which began in 2009, was the first to evaluate MVA85A’s ability to prevent TB disease following BCG vaccination. The study, in infants without TB disease or HIV infection, involved a ‘prime-boost’ strategy that used MVA85A to boost immune responses already primed by the BCG vaccine.
The study enrolled nearly 2,800 HIV-negative infants in the Western Cape province of South Africa. All of the infants that participated in the study received BCG at birth and then one half of the infants received a single dose of MVA85A at 4-6 months of age and the other half received a placebo (Candida skin test antigen). Approximately 93% of the infants enrolled completed the study and have been monitored for up to 37 months for any signs of TB disease. MVA85A was generally well tolerated and the vaccine had a safety profile comparable to other pediatric vaccines. The most frequent side effect observed was mild redness or swelling around the injection site following vaccination.
MVA85A is also being investigated in a Phase IIb efficacy study in people living with HIV in Senegal and South Africa, a Phase IIa study in infants born to HIV positive mothers in South Africa, and Phase I studies in the UK.
More About Tuberculosis (TB)TB is an infectious disease that primarily affects the lungs and can be lethal if left untreated. Symptoms of TB disease can vary from person to person and by age, but may include a frequent, persistent cough (lasting three weeks or more), coughing up of blood, unexplained weight loss, decreased appetite, fatigue, fever, night sweats and chills, and chest pains.
World Health Organization,
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