Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT00749034
Brief Summary:
Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against TB for residents in endemic areas and persons at risk in non-endemic areas. The new live vaccine VPM1002 should be at least as potent as the currently used BCG vaccine and should cause fewer side effects (Kaufmann, 2007; Grode et al., 2005). It is formulated as lyophilised bacteria to be resuspended before intradermal injection. First application of VPM1002 in human male volunteers will evaluate its safety, local and systemic tolerability as well as its immunogenicity. The study has a dose-escalating sequential design with comparison to commercially available BCG. 80 volunteers in Germany will randomly be allocated to 4 groups each with 20 volunteers stratified for their history of BCG-vaccination.
Study:
NCT00749034
Study Brief:
Protocol Section:
NCT00749034