期刊
EXPERT REVIEW OF VACCINES
卷 13, 期 5, 页码 619-630出版社
TAYLOR & FRANCIS LTD
DOI: 10.1586/14760584.2014.905746
关键词
VPM1002; prevention; replacement; prime vaccination; bacille Calmette-Guerin; listeriolysin O; vaccine; Mycobacterium tuberculosis; pre-exposure
类别
资金
- European Union [HEALTH-F3-2009-241745, HEALTH-F4-2011-280873]
- Wellcome Trust [G1100570/1]
- German Ministry for Science and Education [01KI0210]
- IMPAACT
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.
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