Tuberculosis vaccines company Aeras announced on Monday that it will present the positive results from an innovative clinical trial of TB vaccines that could prevent sustained infections in high-risk adolescents at the 5th Global Forum on TB Vaccines in New Delhi, India.
According to Aeras, tuberculosis is designated a priority infectious disease by the WHO. It causes more deaths than any other single infectious disease and is increasingly characterised by antimicrobial resistance. There were 10.4 million new cases of TB in 2016 and 1.7 million deaths.
Under the company's prevention-of-infection Phase 2 trial conducted in South Africa, revaccination with the Bacille Calmette-Guerin (BCG) vaccine reduced sustained TB infections in adolescents. An experimental vaccine candidate, H4:IC31, reduced sustained infections, although not at statistically significant levels.
Aeras said the study involved 990 HIV-negative, healthy adolescents (12 to 17 years of age) who had been vaccinated as infants with BCG. All participants were randomized evenly into three study arms: placebo, H4:IC31, or BCG revaccination.
All participants were screened to ensure they were not infected with Mycobacterium tuberculosis (Mtb) prior to vaccination in the study. The data showed that both vaccines appeared to be safe and produced an immune response in the adolescents studied.
For the primary efficacy endpoint, 134 participants tested positive for an initial Mtb infection as measured by QFT-GIT conversion from negative to positive Observed vaccine efficacy was 20.1% for BCG revaccination and 9.4% for H4:IC31, concluded the company.
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