Date: 2013-11-08
Type of information: Initiation of the trial
phase: 1-2a
Announcement: initiation of the trial
Company: Statens Serum Institut (Denmark) Aeras (USA)
Product: tuberculosis vaccine SSI H56: IC31/AERAS-456
Action
mechanism: SSI H56: IC31/AERAS-456 is a subunit vaccine containing recombinant TB proteins formulated with the proprietary adjuvant IC31® of Valneva.
Disease: tuberculosis
Therapeutic area: Infectious diseases
Country: South Africa
Trial details:
Latest
news: * On November 8, 2013, Statens Serum Institut (SSI) and Aeras have announced the initiation of a Phase I/IIa clinical trial for a candidate tuberculosis (TB) vaccine designed to protect people, especially those latently infected with TB, from developing active TB disease. The decision builds on the outcome of a Phase I study that raised no safety concerns and demonstrated immunogenicity from the first clinical trial of the vaccine candidate, SSI H56:IC31/AERAS-456, formulated with Valneva’s IC31® proprietary adjuvant. The Phase I clinical trial of SSI H56:IC31/AERAS-456, concluded in December 2012, enrolled 25 people. It was the first time a South African research institute led a first-in-human clinical trial. With the second trial, the Phase I/IIa study now underway, the South African Tuberculosis Vaccine Initiative (SATVI) will continue its groundbreaking work.In conducting the Phase I/IIa trial, SATVI will test the vaccine at three dosing levels to evaluate safety as well as immune response in HIV-negative adults—in groups with and without latent tuberculosis.The trial is approved by the Medicines Control Council of South Africa. It is being developed for both adolescent and adult populations. The vaccine candidate has been shown to be immunogenic and protective before and after TB exposure in preclinical animal models.
