Statens Serum Institut (SSI) and Aeras have initiated 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.

“With the results of our first study in hand, we can now test SSI H56:IC31/AERAS-456 for safety in a larger group of individuals, while looking for safety, the correct dose, and the needed immune responses that would lead us into the next phase,” said Thomas G Evans, MD, Aeras president and CEO. “What continues to make this project so strong is the collaboration that brings together Aeras, with deep experience in clinical trials, and SSI, which has unparalleled expertise as an innovator in the basic sciences in TB vaccinology.”

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.

“The current global TB epidemic requires novel approaches, new tools and sufficient resources to reverse what is now a more challenging and expensive disease to control than when the World Health Organization declared it a global emergency more than 20 years ago,” said Professor Peter Andersen at SSI. “The partnership with Aeras and SATVI provides a path to move the research beyond the laboratory and into communities that so desperately needs a safe effective vaccine against this deadly scourge.”

New vaccines are urgently needed to protect against all forms of TB and would represent the single greatest preventative tool in mitigating the epidemic, Evans said, noting that the spread of multi- and extensively drug-resistant strains are hobbling global efforts to halt the spread of TB and are placing an enormous economic burden on health systems globally.

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.

“We are up against one of the hardest vaccine targets science has ever taken on, but we accumulate more knowledge about protection against tuberculosis with every clinical trial,” said Mark Hatherill, associate professor of SATVI. “That is why we need the sort of partnership we have working on this vaccine candidate, and scientists whose work is constantly influenced by what happens all along the pipeline, from the lab to the field and back again. Our strong partnership with the local community is crucial to the success of these tuberculosis vaccine trials.”

SSI H56: IC31/AERAS-456 is a subunit vaccine containing recombinant TB proteins formulated with the proprietary adjuvant IC31 of Valneva. 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.

SSI is a state-owned enterprise under the Danish Ministry of Health and Prevention. SSI's mission is to prevent and control infectious diseases, biological threats and congenital disorders.

Aeras is a non-profit biotech advancing the development of tuberculosis vaccines for the world.