Abstracts (complete list) - Wissenschaft Online

Leander Grode, Hans-Heinrich Henneick v. Zepelin, Albrecht Laeufer, Bernd Eisele
Developing a TB vaccine for human use
Vakzine Projekt Management GmbH (VPM) acquires promising vaccine candidates from
academia, develops them with a consortium of partners and commercializes the results.
With this goal VPM acquired a Tuberculosis vaccine candidate (VPM1002) from Max-
Planck Institute of Infection Biology and develops this candidate through all necessary
stages onto clinical Phase I and II. The project is divided into the three parts technology
transfer & production, preclinic & pharm/tox and clinical Phase I and II.
VPM1002 is a recombinant bacterial vaccine candidate for the prevention of tuberculosis
for residents in endemic areas and persons at risk in non-endemic areas.
It is well known that the existing BCG vaccine offers only little, if any, protection against
pulmonary tuberculosis in adults. VPM1002’s strength is its ability to induce a CD8 T cell
response which is crucial in immunity to M. tuberculosis.
Recombinant M. bovis BCG expressing Listeriolysin (Hly) is able to induce poreformation
in the phagosomal membrane and to leave the mycobacterial phagosome.
The lysis by the Hly can be further enhanced by lowering the pH. Therefore the urease
activity was knocked out by destruction of the ureC gene. Hly promotes antigen
translocation into the cytoplasm and apoptosis of infected target cells, thus promoting a
more profound immune response comprising both antigen-specific CD4 and CD8 T cells.
VPM1002 is manufactured by a novel submerse fermentation in minimal medium. The
final product is a lyophilised cake of live bacteria. Establishment of a GMP process is
completed. The process has been designed to offer full scalability. The GLP
pharmacology is ongoing. The clinical phase I is planned for 2007.