Aeras declared results from Phase 2 TB Vaccine Trial for New BCG Revaccination Strategies

Study is the First "Prevention of Infection" Trial Conducted for Tuberculosis, the World's Leading Infectious Disease Killer.

Non-profit organization, Aeras committed to developing vaccines against TB declared results from breakthrough Clinical Trial aiding evidence that TB Vaccines could forbid sustained infections in high- risk adolescents. Revaccination with the Bacille Calmette-Guerin (BCG) vaccine significantly reduced sustained TB infections in adolescents in a prevention-of infection Phase 2 trial conducted. Experimental vaccine candidate, H4:IC31, also reduced sustained infections, although not at statistically significant levels.

TB infections that developed during the study were determined using a QuantiFERON -TB Gold in Tube (QFT-GIT) test, a commercially available blood test that helps diagnose TB infections. In the trial, individuals who tested negative for QFT-GIT were considered to not have a TB infection. The trial measured the rate by which individuals converted to QFT-GIT positive, implying evidence of TB infection.

According to the World Health Organization (WHO), about one-third of the world’s population has what is called a latent TB infection, which means people have been infected by TB bacteria but are not (yet) ill with the disease and cannot transmit the disease. People infected with TB bacteria have a lifetime risk of falling ill with TB of 10 percent. People ill with TB can infect 10–15 other people through close contact over the course of a year. Without proper treatment, 45% of HIV-negative people with TB on average and nearly all HIV-positive people with TB will die.

Mark Hatherill, MD, Director of the South African Tuberculosis Vaccine Initiative (SATVI) at the University of Cape Town, and the study’s principal investigator, said: “We are pleased to have performed the first-known randomized, placebo-controlled prevention-of-infection trial for TB and to have demonstrated that vaccination has the potential to reduce the rate of sustained TB infection in a high-transmission setting. While neither vaccine proved to be statistically significant in preventing an initial TB infection, we are extremely encouraged by the signals observed for both vaccines in preventing sustained TB infections.”

The study evaluated H4:IC31 vaccination and BCG revaccination for safety, immunogenicity and the ability to prevent initial and sustained TB infections among healthy adolescents in the Western Cape Province of South Africa. H4:IC31 is an investigative subunit vaccine candidate being developed jointly by Aeras and Sanofi Pasteur, the vaccines business of Sanofi (EURONEXT: SAN) (NYSE: SNY), and the Statens Serum Institute. BCG is the only licensed tuberculosis vaccine available globally.

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