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10. Kongress für Infektionskrankheiten und Tropenmedizin (KIT 2010)

Deutsche Gesellschaft für Infektiologie,
Deutsche AIDS-Gesellschaft,
Deutsche Gesellschaft für Tropenmedizin und Internationale Gesundheit,
Paul-Ehrlich-Gesellschaft für Chemotherapie

23.06. - 26.06.2010, Köln

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Induction of antigen specific multifunctional T cells after vaccination with the live recombinant tuberculosis vaccine VPM1002 in a Phase I clinical trial

Induktion von Antigen-spezifischen multifunktionallen T-Zellen nach Vakzinierung mit der lebenden rekombinanten Tuberkulose Vakzine VPM1002 in einer klinischen Phase I- Studie

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  • B. Eisele - Vakzine Projekt Management GmbH, Hannover, Germany
  • L. Grode - Vakzine Projekt Management GmbH, Hannover, Germany
  • H.-H. Henneicke-von Zepelin - Vakzine Projekt Management GmbH, Hannover, Germany
  • C. Desel - Max Planck Institute f. Infection Biology, Berlin, Germany
  • J. Maertzdorf - Max Planck Institute f. Infection Biology, Berlin, Germany
  • S. H. Kaufmann - Max Planck Institute f. Infection Biology, Berlin, Germany

10. Kongress für Infektionskrankheiten und Tropenmedizin (KIT 2010). Köln, 23.-26.06.2010. Düsseldorf: German Medical Science GMS Publishing House; 2010. DocINF 09-3

doi: 10.3205/10kit018, urn:nbn:de:0183-10kit0188

Published: June 2, 2010

© 2010 Eisele et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

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Introduction: VPM1002 is a live vaccine against tuberculosis (TB). It is based on the well known Mycobacterium bovis Bacille Calmette-Guérin (BCG) strain which has been applied appr. 4 billion times world wide. As BCG is not sufficiently effective to stop the spread of TB, two modifications have been implemented in VPM1002 to improve its immunogenicity. Our Phase I study in humans used multiparameter flow cytometry to characterize the quality of the T cell response following immunization with our VPM1002 tuberculosis vaccine candidate or BCG.

Methods: In a Phase I open label, randomized, controlled, dose-escalation study to valuate safety and immunogenicity of VPM1002 in comparison with BCG. We enrolled 80 healthy male subjects stratified for history of BCG vaccination.

Results: Safety and tolerability revealed no serious adverse reactions from VPM1002 vaccination and only mild to moderate adverse reactions were reported. VPM1002 was very well tolerated in both cohorts the naïve and BCG pre-immunized volunteers. Higher total IFN-gamma production was measured in the VPM1002 group vs. the BCG group. VPM1002 induced a good multifunctional CD4+ and CD8+ T cell response in comparison with BCG.

Discussion and conclusion: VPM1002 induces multifunctional T cell subsets which are thought to play a crucial role in protection against tuberculosis. At the same time VPM1002 is very well tolerated and presents a safety profile that is similar or even better than BCG. VPM1002 shows all characteristics for a safe, well tolerated and efficacious tuberculosis vaccine, which could replace BCG immunization in the future.