11 January 2012

The combination of SSI’s novel tuberculosis subunit vaccine candidate and Intercell’s proprietary IC31® adjuvant enters Phase II clinical trial in HIV-positive individuals. First results expected in 2013, a second Phase II study is planned for 2012.

Intercell AG (VSE; "ICLL") and Statens Serum Institut (SSI) today announced the start of the first Phase II study within their collaboration to develop vaccines against Tuberculosis (TB). The randomised, double-blind, clinical trial evaluating the immunogenicity and safety of two doses of an adjuvanted TB subunit vaccine candidate, H1IC (a combination of SSI’s Ag85B-ESAT-6 + Intercell’s IC31®), in HIV-positive individuals, will be conducted in South Africa and Tanzania.

The study is funded by EDCTP (European and Developing Countries Clinical Trials Partnership) and conducted in collaboration with Aurum Institute, Ifakara Health Institute, Swiss Tropical and Public Health Institute, London School of Hygiene and Tropical Medicine and the South African TB Vaccine Initiative.

First results are expected in 2013. A second Phase II clinical study is being planned to assess the safety and immunogenicity of the vaccine candidate in healthy adolescents.

Previous Phase I clinical trials in Europe and Africa have demonstrated that SSI and Intercell’s collaborative novel investigational TB vaccine is safe and very immunogenic in different populations. The new H1IC vaccine candidate from SSI is a recombinant subunit vaccine based on two important TB antigens resulting from SSI’s research pipeline combined with Intercell’s proprietary adjuvant IC31® and ultimately targeted against adults and adolescents.

“We are very proud that the clinical evaluation of the H1IC vaccine is progressing so well and that this vaccine is playing a key role in the development of a much-needed novel efficient TB vaccine”, say’s Peter Lawætz Andersen, Vice President Vaccine R&D, SSI.

“The start of this Phase II clinical trial is not only a further validation of Intercell’s proprietary IC31® adjuvant technology, it is foremost an notable step towards addressing an important medical need with a novel vaccine against TB”, says Thomas Lingelbach, CEO of Intercell AG.

The collaboration between SSI and Intercell in the field of Tuberculosis currently includes three clinical vaccine candidates, all formulated with Intercell’s IC31® adjuvant: H1IC, now entering Phase II, H4IC, currently in Phase I (partnered with Sanofi and AERAS, “AERAS 404”), and H56IC, currently in a Bill and Melinda Gates Foundation-funded Phase I in partnership with AERAS and the South African Tuberculosis Vaccine Initiative.
About Tuberculosis

Tuberculosis (TB) causes the death of more than 1.5 million people every year and one‐third of the world’s population is infected by the bacteria “Mycobacterium tuberculosis” which makes this disease one of the most severe global health problems. The existing Bacillus Calmette‐Guérin vaccine (BCG) vaccine is a live vaccine that, when given to newborns, provides good protection against TB for 10‐15 years. However, when the protective effect decreases, yet another BCG vaccination does not provide sufficient TB protection. Therefore, a new type of TB vaccine is needed to address the need of TB protection in the adult population.
About IC31®

As modern vaccines based on pure recombinant or synthetic antigens are generally less immunogenic than conventional live or killed whole organism vaccines, there is an increasing need for potent new adjuvants.
IC31® is an injectable synthetic adjuvant which combines the immunostimulating properties of an oligodeoxynucleotide, ODN1a, and a cationic anti-microbial peptide, KLK. It activates antigen presenting cells (APCs) via the TLR9 (Toll-like receptor 9) signaling pathway and numerous pre-clinical studies indicate the induction of strong and particularly long-lasting T-cell and B-cell responses.

IC31® is used as adjuvant in vaccine candidates developed by global vaccine companies. It has been tested in humans in several Phase I clinical trials where it has shown a favourable safety and tolerability profile. In combination with novel recombinant Tuberculosis vaccine candidates developed in collaboration with the Statens Serum Institut (DK), sanofi pasteur and AERAS, IC31® has demonstrated the potential to induce strong and sustained T-cell responses in humans.
About Statens Serum Institut (SSI)

SSI is a public enterprise operating as a market-oriented production and service enterprise. SSI is an enterprise under the Danish Ministry of Health and Prevention, and the Institute’s duties are partly integrated in the national Danish health services. SSI prevents and controls infectious diseases, biological threats, and congenital disorders.

SSI aims to ensure advanced control of infectious diseases, including new infections and biological threats. The institute also strives to be a highly regarded and recognized national and international research, production and service enterprise.

For more information please visit: www.ssi.dk