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. 2018 May 14;14(7):1697–1716. doi: 10.1080/21645515.2018.1458806

Table 1.

Vaccine candidates in clinical development.

Vaccine type Vaccine name Vaccine composition S&C a Strategy b Phase CTR Number c Status d
Inactivated TB Utilins Heat-killed M. phlei FAHGMU IT III ChiCTR-TRC-11001189 Completed
vaccines M. smegmatis An acellular M. smegmatis vaccine NICPBP IT I Unknown Completed
  Vaccae™ Heat-killed whole M. vaccae AZLBP IT III NCT01979900 Completed
  MIP/Mw Heat-killed M. indicus pranii DBT IT III NCT00265226 Completed
            NCT00341328 Completed
  RUTI® Detoxified liposomal fragments of M. tuberculosis AFSL, Parexel IT IIa NCT01136161 Completed
            NCT02711735 Not yet recruiting
  DAR-901 Heat-killed M. tuberculosis DMHC, Aeras, NIAID B IIb NCT02712424 Active, not recruiting
Recombinant VPM1002 rBCG expressing listeriolysin and lacking urease gene SIIP, SGCCR, VPMG P IIb/III NCT02391415 Active, not recruiting
live vaccines           NCT03152903 Not yet recruiting
  rBCG30 rBCG over-expressing Ag85B Aeras P I Unknown Completed and stopped
  AERAS-422 rBCG over-expressing Ag85A, Ag85B, and Rv3407 Aeras, AI, DIM, DPID, SB P I NCT01340820 Completed and stopped
  MVA85A/ A recombinant strain of modified MVA expressing Ag85B from M. tuberculosis Aeras, UOXF, EDCTP, UCT, MRC B IIb NCT01151189 Completed
  AERAS-485         NCT00953927 Completed
            NCT02178748 Completed
  Ad35/AERAS-402 A replication-deficient adenovirus type 35 expressing Ag85A, Ag85B, and TB10.4. Aeras, EDCTP, CHBV B II NCT02414828 Completed
            NCT01017536 Completed
            NCT01198366 Completed
  Ad5Ag85A A human adenovirus serotype 5 expressing Ag85A. MU, CIHR B I NCT00800670 Terminated
            NCT02337270 Recruiting
  ChAdOx1.85A A recombinant simian adenovirus expressing Ag85A. UOXF, UB B I NCT01829490 Completed
  TB/FLU-04L A live recombinant influenza vector expressing Ag85A and ESAT-6. RIBSP, RII B IIa NCT02501421 Completed
Attenuated live MTBVAC Genetically attenuated phoP-fadD26-deletion mutant of M. tuberculosis BLS, Aeras, UZ, CHUV, TBVI P Ib/IIa NCT02729571 Active, not recruiting
vaccines           NCT02933281 Not yet recruiting
TB subunit vaccines AEC/BC02 Fusion protein Ag85b-ESAT6-CFP10 in BC02 adjuvant AZLBP, NIFDC B I NCT03026972 Not yet recruiting
  BCG-PSN Polysaccharide and nucleic acid extracted from BCG JZT IT I Unknown Unknown
  Mtb72F Fusion protein Mtb32a-Mtb39a in AS01E or AS02A adjuvant GSK, Aeras B IIb NCT02097095 Completed
            NCT01755598 Active, not recruiting
  H1:IC31 Fusion protein Ag85B-ESAT-6 in IC31 adjuvant SSI, TBVI, EDCTP B II PACTR201105000289276 Completed
  H1:CAF01 Fusion protein Ag85B-ESAT-6 in CAF01 adjuvant SSI B I NCT00922363 Completed
  H1:LTK63 Fusion protein Ag85B-ESAT-6 in LTK63 adjuvant SGUL, SSI B I NCT00440544 Terminated
  H4:IC31/ Fusion protein Ag85B-TB10.4 in IC31 adjuvant Aeras, SSI, SP B IIa NCT02075203 Completed
  AERAS-404         NCT01861730 Active, not recruiting
  H56:IC31/ Fusion protein Ag85B-ESAT-6-Rv2660c in IC31 adjuvant SSI, Aeras, SP B IIa NCT01865487 Completed
  AERAS-456         NCT03265977 Not yet recruiting
  ID93+GLA-SE Fusion protein Rv2608-Rv3619-Rv3620-Rv1813 in GLA-SE adjuvant IDRI, WT, SATVI B IIa NCT02465216 Completed
DNA vaccines GX-70 Four-antigen plasmids from MTB together with Flt3 ligand. YU IT I NCT03159975 Not yet recruiting
a

: Sponsors and collaborators. AFSL: Archivel Farma S.L. (Spain); AI: Aurum Institute (South Africa); AZLBP: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd (China); BSL: Biofabri, S.L (Spain); CHBV: Crucell Holland BV (Netherlands); CHUV: Centre Hospitalier Universitaire Vaudois (Switzerland); CIHR: Canadian Institutes of Health Research (Canada); DPID: Division of Pediatric Infectious Diseases, Columbia University; DBT: Department of Biotechnology (India); DIM: Department of Internal Medicine, Saint Louis University (USA); DHMC: Dartmouth-Hitchcock Medical Center (USA); EDCTP: European & Developing Countries Clinical Trials Partnership; FAHGMU: First Affiliate Hospital of Guangxi Medical University (China); GSK: Glaxo-SmithKline Biologicals (UK); IDRI: Infectious Disease Research Institute; IP: Institute Pasteur (France); JZT: Jiuzhitang Co., Ltd (China); MRC: MRC/UVRI Uganda Research Unit on Aids; MU: McMaster University (Canada); NIAID: National Institute of Allergy and Infectious Diseases (USA); RIBSP: Research Institute for Biological Safety Problems (Kazakhstan); NICPBP: National Institute for the Control of Pharmaceutical and Biological Products (China); NIFDC: National Institutes for Food and Drug Control (China); RII: Research Institute on Influenza (Russia); SATVI: South African Tuberculosis Vaccine Initiative (South African); SB: Seattle BioMed (USA); SGCCR: Swiss Group for Clinical Cancer Research (Germany); SGUL: St George's, University of London (UK); SIIP: Serum Institute of India Pvt. Ltd (India); SSI: Statens Serum Institute (Denmark); SP: Sanofi Pasteur (Canada); TBVI: TB Vaccine Initiative (Netherland); UB: University of Birmingham; UCT: University of Cape Town; UOXF: University of Oxford; UZ: University of Zaragoza (Spain); VPMG: Vakzine Projekt Management GmbH (Germany); WT: Wellcome Trust (UK); YU: Yonsei University (Korea).

b

: B: Boosting vaccine; IT: Therapeutic vaccine; P: Priming vaccine.

c

: CTR number: Clinical trial registration number; NCT number: ClinicalTrials.gov Identifier; PACTR number: Pan African Clinical Trials Registry; ChiCTR-TRC number: Chinese Clinical Trial Registry. Only the latest clinical trials were listed here.

d

: The status of each trial was offered by ClinicalTrials.gov data bank (https://clinicaltrials.gov/ct2/home), Pan African Clinical Trials Registry (http://www.pactr.org/), or Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx). the data were obtained at October 31, 2017.