Statens Serum Institut and Aeras have announced the initiation of the first Phase I clinical trial of a new candidate TB vaccine designed to protect people latently infected with TB from developing active TB disease.
The trial is being conducted by the South African Tuberculosis Vaccine Initiative (SATVI) at its field site in Worcester, in the Western Cape province of South Africa.
“Two billion men, women and children live with latent TB infection,” Jim Connolly, President and Chief Executive Officer of Aeras, said.
“It’s daunting to comprehend that there is a vast reservoir of people with a 5-10 percent lifetime risk of becoming sick with TB. A vaccine that prevents TB disease in this population could save millions of lives, and this trial is a first step in assessing a vaccine candidate designed for this purpose,” he said.
The candidate TB vaccine (SSI H56-IC31) is a subunit vaccine containing recombinant TB proteins formulated in a proprietary adjuvant IC31 from Intercell. It is being developed under a consortium of researchers led by Peter Andersen at the Statens Serum Institut (SSI) based in Copenhagen.
“The development of urgently needed new TB vaccines requires a global effort,” Prof. Peter Andersen, the Vice President of Vaccine Research and Development at SSI, said.
“The advancement of this candidate from an idea to the clinic working in collaboration first with the Grand Challenges consortium and now with Aeras and SATVI is an important and exciting milestone for all the researchers involved,” he said.
This clinical trial will be the first to test this vaccine candidate in people. It will assess the safety and immunogenicity of SSI H56-IC31 in 25 adults, including participants with and without latent TB infection.