Table 1

Tuberculosis vaccine candidates in clinical trials

Clinical trial statusVaccine nameDescriptionType of vaccineMono/Pauci/Poly antigenicProposed useClinical end-pointsEfficacy tested in NHP and/or Bovine modelsEfficacy greater than BCG in NHP/Bovine models
Phase IIIDAR-901Whole cell non-tuberculous mycobacteriaInactivated mycobacteriaPolyantigenBoost BCGPrevention of tuberculosis disease in adolescents and adultsBovineNo16
Phase IIbMVA85A/AERAS-485Modified Vaccinia Ankara vector expressing antigen 85AViral vectorMonoantigenBoost BCGPrevention of infection, disease and reactivationNHP and BovineNo5 6
Phase IIbAERAS-402/Crucell Ad35Adenoviral vector expressing antigen 85A, 85B, TB10.4Viral vectorPauciantigenBoost BCGPrevention of infection and diseaseNo–
Phase IIVPM 1002Recombinant BCG strain expressing listeriolysin and carrying a urease deletion mutationRecombinant live attenuated mycobacteriaPolyantigenBoost/Replace BCGPrevention of infection and diseaseNo–
Phase IIRUTILiposomed fragments of MtbWhole cell vaccinePolyantigenAdjunct to LTB INH prophylaxis/Boost BCGPrevention of infection, disease and reactivationNo–
Phase IIM72Recombinant fusion protein of Mtb antigens RV1196 and Rv0125 with AS01 adjuvantRecombinant proteinPauciantigenReplace BCGPrevention of infection and diseaseNHPYes17
Phase IIH1-IC31Recombinant fusion protein of Mtb antigens 85B, ESAT-6 with IC31 adjuvantRecombinant proteinPauciantigenBoost/Replace BCGPrevention of infection and diseaseNo–
Phase IAdAg85ARecombinant adenoviral vector expressing antigen 85AViral vectorMonoantigenBoost/Replace BCGPrevention of infection and diseaseBovineNo5
Phase IAERAS-422Recombinant BCG strain expressing mutation PfoA and Mtb antigens 85A, 85B and TB10.4Recombinant live attenuated mycobacteriaPolyantigenReplace BCGPrevention of infection and diseaseNo–
Phase IrBCG30Recombinant BCG strain expressing Mtb antigen 85BRecombinant live attenuated mycobacteriaPolyantigenBoost BCGPrevention of infection and diseaseNo–
Phase IID93/GLA-SERecombinant fusion protein of Mtb antigens Rv2608, Rv3619, Rv3620 and Rv1813 with GLA-SE adjuvantRecombinant proteinPauciantigenBoost/Replace BCGPrevention of infection and diseaseNo–
Phase IH4-IC31Recombinant fusion protein of Mtb antigens 85B, TB10.4 with IC31 adjuvantRecombinant proteinPauciantigenBoost BCGPrevention of infection and diseaseNo–
Phase IH1-CAF01Recombinant fusion protein of Mtb antigens 85B, ESAT-6 with CAF01 adjuvantRecombinant proteinPauciantigenBoost/Replace BCGPrevention of infection and diseaseNo–
Phase IH56-IC31Recombinant fusion protein of Mtb antigens 85B, ESAT-6 and Rv2660 with IC31 adjuvantRecombinant proteinPauciantigenBoost/Replace BCGPrevention of infection, disease and reactivationNHPNo18

  • Mtb, Mycobacterium tuberculosis; NHP, non-human primate; BCG, Bacillus Calmette-Guerin.