Data from: Safety and immunogenicity of H1/IC31®, an adjuvanted TB subunit vaccine, in HIV-infected adults with CD4+ Lymphocyte counts greater than 350 cells/mm3: a phase II, multi-centre, double-blind, randomized, placebo-controlled trial

Klaus Reither, Lynn Katsoulis, Trevor Beattie, Nicolene Gardiner, Nicole Lenz, Khadija Said, Elirehema Mfinanga, Christian Pohl, Katherine L. Fielding, Hannah Jeffery, Benjamin M. Kagina, Elisabeth J. Hughes, Thomas J. Scriba, Willem A. Hanekom, Søren T. Hoff, Peter Bang, Ingrid Kromann, Claudia Daubenberger, Peter Andersen & Gavin J. Churchyard
Background: Novel tuberculosis vaccines should be safe, immunogenic, and effective in various population groups, including HIV-infected individuals. In this phase II multi-centre, double-blind, placebo-controlled trial, the safety and immunogenicity of the novel H1/IC31 vaccine, a fusion protein of Ag85B-ESAT-6 (H1) formulated with the adjuvant IC31, was evaluated in HIV-infected adults. Methods: HIV-infected adults with CD4+ T cell counts >350/mm3 and without evidence of active tuberculosis were enrolled and followed until day 182. H1/IC31 vaccine or...
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