The BCG replacement vaccine VPM1002: from drawing board to clinical trial.
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 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.
Department of Immunology, Max Planck Institute for Infection Biology, Berlin, Germany.
Stefan He
SH
Kaufmann
Mark F
MF
Cotton
Bernd
B
Eisele
Martin
M
Gengenbacher
Leander
L
Grode
Anneke C
AC
Hesseling
Gerhard
G
Walzl
D000818:Animals; D001500:BCG Vaccine / Q000008:administration & dosage*; D002986:Clinical Trials as Topic / Q000639:trends*; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000187:drug effects* / Q000502:physiology; D014376:Tuberculosis / Q000453:epidemiology / Q000517:prevention & control*
D001500:BCG Vaccine