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There is an urgent need for an immunological correlate of protection against tuberculosis (TB) with which to evaluate candidate TB vaccines in clinical trials. Development of a human challenge model of Mycobacterium tuberculosis (M.tb) could facilitate the detection of such correlate(s). Here we propose a novel in vivo Bacille Calmette-Guérin (BCG) challenge model using BCG immunization as a surrogate for M.tb infection. Culture and quantitative PCR methods have been developed to quantify BCG in the skin, using the mouse ear as a surrogate for human skin. Candidate TB vaccines have been evaluated for their ability to protect against a BCG skin challenge, using this model, and the results indicate that protection against a BCG skin challenge is predictive of BCG vaccine efficacy against aerosol M.tb challenge. Translation of these findings to a human BCG challenge model could enable more rapid assessment and down selection of candidate TB vaccines and ultimately the identification of an immune correlate of protection.

Original publication

DOI

10.1371/journal.pone.0019840

Type

Journal article

Journal

PLoS One

Publication Date

2011

Volume

6

Keywords

Animals, BCG Vaccine, Cells, Cultured, Enzyme-Linked Immunosorbent Assay, Female, Flow Cytometry, Humans, Mice, Mice, Inbred BALB C, Mycobacterium tuberculosis, Polymerase Chain Reaction, Tuberculosis Vaccines