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Results from innovative tuberculosis vaccine trial show potential for new BCG revaccination strategies and hope for subunit vaccines.

12 Jul 2018 - 08:15

 

 

Scientists from the South African Tuberculosis Vaccine Initiative (SATVI) and the Desmond Tutu HIV Foundation have announced publication in the New England Journal of Medicine of the results of an innovative clinical trial that provides encouraging new evidence that TB vaccines could prevent sustained TB infections in high-risk adolescents. our latest TB vaccine clinical trial have been published in the New England Journal of Medicine.

In a prevention-of-infection phase 2 trial conducted in Worcester and Cape Town, South Africa, revaccination with the Bacille Calmette-Guerin (BCG) vaccine significantly reduced sustained TB infections in adolescents.  An experimental vaccine candidate, H4:IC31, also appeared to reduce sustained infections, although not at statistically significant levels. However, the trend observed for H4:IC31 is the first time a subunit vaccine has shown any indication of ability to protect against TB infection or disease in humans.

Joint SATVI/DTHF press release. Click here.

Aeras press release. Click here.

Study fact sheet. Click here.

In a prevention-of-infection phase 2 trial conducted in Worcester and Cape Town, South Africa, revaccination with the Bacille Calmette-Guerin (BCG) vaccine significantly reduced sustained TB infections in adolescents.  An experimental vaccine candidate, H4:IC31, also appeared to reduce sustained infections, although not at statistically significant levels. However, the trend observed for H4:IC31 is the first time a subunit vaccine has shown any indication of ability to protect against TB infection or disease in humans.
TB infections that developed during the study were measured 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 TB infection. The trial measured the rate by which individuals converted to QFT-GIT positive, interpreted as evidence of TB infection. Those individuals who tested QFT-GIT positive consecutively over 6 months were considered to have a sustained infection.


H4:IC31 is a subunit TB vaccine candidate being developed jointly by Aeras and Sanofi Pasteur, and the Statens Serum Institute. BCG is the only licensed tuberculosis vaccine available globally. The clinical trial was conducted at SATVI and at the Emavundleni Research Centre (part of the Desmond Tutu HIV Centre). The trial was funded by Sanofi Pasteur, the United Kingdom’s Department for International Development, and Aeras. The study was approved by the Medicines Control Council of South Africa and the independent ethics committee of the University of Cape Town.

For more information visit:

South African Tuberculosis Vaccine Initiative

Desmond Tutu HIV Foundation

Aeras