Clinical test of a new vaccine treating latent TB infection
The medical professionals of Statens Serum Institute stated about the first Phase I clinical trial of a new candidate TB vaccine made to protect people with latent TB from developing active TB disease. The study is organized by the South African Tuberculosis Vaccine Initiative (SATVI) with Dr. Hassan Mahomed at the head.
Jim Connolly, President and Chief Executive Officer of Aeras said that 2 billion people live with latent TB. Many of them have a 5-10% risk of being infected with TB. This study is very important, because this new vaccine can prevent TB and save millions of lives.
The new TB vaccine (SSI H56-IC31) is a subunit vaccine consisting of recombinant TB proteins formulated in a proprietary adjuvant IC31 from Intercell. The research is under a arrangement of researchers with Peter Andersen from Statens Serum Institut (SSI) at the head. The arrangement is a part of the Grand Challenges in Global Health, an initiative that promotes scientific breakthroughs in order to prevent, treat and cure diseases all over the world.
Prof. Peter Andersen, the Vice President of Vaccine Research & Development at SSI, announced:
"For all the researchers it is a very important milestone the advancement of this candidate from an idea to the clinic working in cooperation first with the Grand Challenges arrangement and now with Aeras and SATVI."
It will be the first clinical trial to test this vaccine candidate in 25 people with and without latent TB infection. SSI H56-IC31 has been successfully tested in small animal models. It has been given both before infection and to latently infected animals.
The vaccine also showed a control of clinical disease and reactivation in a non-human primate model. This is the first time a South African research institute has led a first-in-human Phase I clinical study of a new TB vaccine.
SSI H56-IC31 is under development for both infants and adults. The study has been approved by the Medicines Control Council of South Africa. The final results of this study are expected at the end of 2012.
Comments
(0)