The BCG replacement vaccine VPM1002: from drawing board to clinical trial

作者：Kaufmann Stefan H E^*; Cotton Mark F; Eisele Bernd; Gengenbacher Martin; Grode Leander; Hesseling Anneke C; Walzl Gerhard

来源：Expert Review of Vaccines, 2014, 13(5): 619-630.

DOI：10.1586/14760584.2014.905746

• VPM1002
• prevention
• replacement
• prime vaccination
• bacille Calmette-Guerin
• listeriolysin O
• vaccine
• Mycobacterium tuberculosis
• pre-exposure

Tuberculosis remains a major health threat and vaccines better than bacillus Calmette-Guerin (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 Mycobacterium tuberculosis 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.

• 出版日期2014-5