Cooperation to create a new Tuberculosis vaccine

Max Planck Institute for Infection Biology and MOLOGEN initiate development of a new tuberculosis subunit vaccine

October 08, 2004

A cooperation agreement to initiate the development of a new type of preventive DNA subunit vaccine against tuberculosis (TB) has been signed by the Max Planck Institute for Infection Biology (MPI-IB) and MOLOGEN AG in Berlin. Subunit vaccines are composed of defined molecular immunogenic modules. Under its director Prof. Dr. Stefan H. E. Kaufmann, the Department of Immunology at the MPI-IB is studying the mechanisms of host - pathogen interactions and develops novel vaccination strategies; it is amongst the leading groups in Tuberculosis immunology research world wide. MOLOGEN focuses on proprietary DNA technologies to develop treatments for non- or inadequately treatable diseases.

With more than 2 million deaths and 9 million new infections annually, TB, along with malaria and HIV/AIDS, is responsible for the greatest number of infectious disease victims world wide. Of particular concern is the increasing number of pathogens resistant to conventional medication. The World Health Organisation estimates that some 50 million people around the globe are already infected with such multi-resistant strains. As the current TB vaccine BCG fails to protect against the most common form of the disease, pulmonary TB in adults, the need for an efficacious tuberculosis vaccine is more urgent than ever.

"The only prevention of TB is the viable BCG vaccine (Bacillus-Calmette-Guérin), which has been in use since 1921," says MPI-IB director Prof. Stefan H.E. Kaufmann. "BCG has a proven safety record for many decades, however, it unfortunately lacks effectiveness," notes Kaufmann, adding that only children can be protected against certain forms of TB by BCG. "…however, BCG does not protect against pulmonary TB in adults at all. We assume the protection provided by BCG to be so limited because BCG bacteria fail to induce the complete immune response required for the control of TB".

The prime - boost" vaccination regime combining BCG and the new DNA vaccine has the potential to overcome this hurdle. DNA vaccines deliver genetic information directly into the cells of the vaccinated person, which enables the cells to produce the most appropriate and efficacious vaccine via the safest possible application method. DNA vaccines induce a distinct type of immune response that cannot be attained by traditional vaccines, and which is needed to fight many diseases that can not be treated so far, Tubersulosis being among them. With MIDGE (Minimalistic Immunogenically Defined Gene Expression) MOLOGEN has developed a unique, safe and efficient technology for this new generation of vaccines.

The vaccine regime jointly investigated by MPI-IB and MOLOGEN is based on a first vaccination ("prime") with the current TB vaccine BCG, followed by one or several repetitive vaccinations ("boost") with the DNA vaccine. The first round of experiments will take about 18 months. The objective is to prevent the disease in the lung (pulmonary TB). To prevent the outbreak of TB after an infection, a complex cellular immune response against the pathogen has to be stimulated. In other fields, MOLOGEN has already demonstrated that its DNA vaccines stimulate the cellular immune response against infectious agents much more efficiently than other current vaccines.

MOLOGEN CEO Prof. Burghardt Wittig states: "From the successful results obtained with our DNA vaccines against the parasite causing leishmaniasis we assume that our technology can also protect against the bacteria causing TB. With Stefan Kaufmann and the MPI-IB we have found a highly renowned and experienced partner for this challenging mission. This still is a preclinical stage project, but our cooperation will add significant value to this new vaccination approach. There is a significant commercial perspective in developing as well as in developed countries. If our tests prove successful we will decide if we carry on with this project on our own, or if we invite third parties to finance a co-development scheme."

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