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

Statens Serum Institut (SSI) in Copenhagen Denmark 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 in South Africa and Tanzania.

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.

Grafik der viser TB i lungerne

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 or +45 32683940

FACTSHEET

  • The European and Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003 as a European response to the global health crisis of poverty-related diseases. It is a public-public partnership between countries in Europe and sub-Saharan Africa and supported by the European Union under Horizon 2020, it's Framework Programme for Research and Innovation.
  • The objective is to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa with a focus on phase II and III clinical trials.
  • EDCTP has a total budget of EUR 1.5 billion. Thus, EDCTP is an important source of funding for international research in infectious diseases.
  • The Bacille Calmette-Guérin vaccine has been used since 1921. Since then more than 4 billion children have been vaccinated, and the vaccine is part of the children’s vaccine program in more than 100 countries.
  • The Calmette vaccine is made from a weakened strain of TB bacteria. Because the bacteria in the vaccine is weak, it triggers the immune system to protect against the disease, giving good immunity to people who receive it without actually causing the disease.
  • New TB vaccines such as H56:IC31 work by directing the immune system of the body towards important parts of the TB bacteria. Therefore, the new vaccines are expected to be more precise and safe.
  • The H56:IC31 vaccine is developed by SSI and uses the adjuvant IC31®, developed by Valneva.

 

Search in R & D news: