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Statens Serum Institut and Aeras today announce the initiation ofthe first Phase I clinical trial of a new candidate TB vaccinedesigned to protect people latently infected with TB fromdeveloping active TB disease. The trial is being conducted by theSouth African Tuberculosis Vaccine Initiative (SATVI) at its fieldsite in Worcester, in the Western Cape province of South Africa.Dr. Hassan Mahomed is the principal investigator. "Two billion men, women and children live with latent TBinfection," said Jim Connolly, President and Chief ExecutiveOfficer of Aeras. "It's daunting to comprehend that there is a vastreservoir of people with a 5-10% lifetime risk of becoming sickwith TB. A vaccine that prevents TB disease in this populationcould save millions of lives, and this trial is a first step inassessing a vaccine candidate designed for this purpose." The candidate TB vaccine (SSI H56-IC31) is a subunit vaccinecontaining recombinant TB proteins formulated in a proprietaryadjuvant IC31® from Intercell. It is being developed under aconsortium of researchers led by Peter Andersen at the StatensSerum Institut (SSI) based in Copenhagen. The consortium issupported as part of the Grand Challenges in Global Health, aninitiative that fosters scientific breakthroughs needed to prevent,treat and cure diseases of the developing world. "The development of urgently needed new TB vaccines requires aglobal effort," said Prof. Peter Andersen, the Vice President ofVaccine Research & Development at SSI. "The advancement of thiscandidate from an idea to the clinic working in collaboration firstwith the Grand Challenges consortium and now with Aeras and SATVIis an important and exciting milestone for all the researchersinvolved." This clinical trial will be the first to test this vaccinecandidate in people. It will assess the safety and immunogenicityof SSI H56-IC31 in 25 adults, including participants with andwithout latent TB infection. SSI H56-IC31 has been tested inseveral pre-clinical studies with no safety concerns and has shownefficacy in small animal models administered both before infectionand to latently infected animals. The vaccine was also shown tocontrol clinical disease and reactivation in a non-human primatemodel. This is the first time a South African research institutehas led a first-in-human Phase I clinical trial of a new TBvaccine. "SATVI is delighted to be part of the trial at this early stage,which is testament to the high-regard that the developers have forour TB vaccine clinical research expertise to conduct these crucialearly trials in humans," said SATVI Director, Professor WillemHanekom. SSI H56-IC31 is being developed for both adolescent and adultpopulations. The trial has been approved by the Medicines ControlCouncil of South Africa. Preliminary results of this trial areexpected at the end of 2012. Additional References Citations. I am an expert from retortpouchpackaging.com, while we provides the quality product, such as 3 Side Seal Pouch Manufacturer , Aluminium Foil Pouches Manufacturer, Retort Pouch Packaging,and more.
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