The BCG replacement vaccine VPM1002: from drawing board to clinical trial. (May 2014)

• Record Type: Journal Article
• Authors: Kaufmann, Stefan HE; Cotton, Mark F; Eisele, Bernd; Gengenbacher, Martin; Grode, Leander; Hesseling, Anneke C; Walzl, Gerhard
• Is Part Of: Expert review of vaccines. Volume 13:Number 5(2014)
• Page Start: 619
• Page End: 630
• Publication Date: 2014-05
• Subjects: Vaccines -- Periodicals; Vaccination -- Periodicals; 615.37205
• DOI: 10.1586/14760584.2014.905746
• Languages: English
• ISSNs: 1476-0584

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p>Tuberculosis remains a major health threat and vaccines better than bacillus Calmette-Guérin (BCG) are urgently required. Here we describe our experience with a recombinant BCG expressing listeriolysin and deficient in urease. This potential replacement vaccine has demonstrated superior efficacy and safety over BCG in <italic>Mycobacterium tuberculosis</italic> aerosol-challenged mice and was safe in numerous animal models including immune-deficient mice, guinea pigs, rabbits and nonhuman primates. Phase I clinical trials in adults in Germany and South Africa have proven safety and a current Phase IIa trial is under way to assess immunogenicity and safety in its target population, newborns in a high tuberculosis incidence setting, with promising early results. Second-generation candidates are being developed to improve safety and efficacy.</p> </abstract>