SSI receives EUR 13.8 million grant from EDCTP to test new tuberculosis (TB) vaccine

Statens Serum Institut (SSI) has been granted a sum of EUR 13.8 million from the European & Developing Countries Clinical Trial Partnership (EDCTP).

The grant will finance the trial of a new and promising TB vaccine developed by SSI. The trial will use prevention of TB recurrence post-TB treatment as an indicator of the ability of the vaccine to prevent TB disease in the broader population and is the first of its kind to be conducted.

The trial project will be done in South Africa and Tanzania by a consortium coordinated by SSI involving seven other partners from South Africa, Tanzania and Italy.

Globally, tuberculosis is the infectious disease costing most lives. Every year approx. 10 million people become infected and 1.7 million die.

The Bacille Calmette-Guérin vaccin is the only TB vaccine available. It came on the market almost 100 years ago and is still being used. It is partially effective in children, but the effect weakens gradually over time. Therefore, it only offers very little protection in adults. Researchers have worked many years on creating a new vaccine that can prolong the effect.

The project was launched in Cape Town, South Africa, last week. The consortium will enroll 900 participants at the end of active TB treatment, randomized to receive either placebo or the H56:IC31 vaccine from SSI. Study participants will be followed closely for 12 months after the vaccination to assess the vaccine’s ability to prevent the 4-8% recurrences normally seen during the first year after treatment.

Promising vaccine

SSI has great expectations to the new vaccine.

“In this trial we implement a novel trial concept for the first time. Based on a solid preclinical assessment of this vaccine in several animal models combined with a very promising safety profile in humans, we are confident that we give this new concept the best chance for success. If we are able to show vaccine efficacy, it will be a game changer in the TB vaccine field, providing valuable proof of concept for therapeutic use of TB vaccines, a major achievement in the fight against this high priority disease. We are very pleased to contribute to the global fight against TB”, says Peter Andersen, Executive Vice President, Center for Vaccine Research, SSI.

For further information please contact Dr Morten Ruhwald, SSI, at moru@ssi.dk or +45 32683940