Table 2.
Major TB vaccine candidates in clinical trials:.
| Vaccine candidate | Composition | Clinical Trial | Clinical trial Identifier | Ref. |
|---|---|---|---|---|
| Inactivated whole-cell vaccines | ||||
| DAR-901 | Inactivated Mycobacterium obusense | Phase 2, randomized, placebo-controlled, double-blind study to evaluate the efficacy of DAR-901 TB booster to prevent TB in adolescents. | NCT02712424 | (1) |
| MIP | Inactivated Mycobacterium indicus pranii | Phase 3, randomized, double-blind, interventional study to determine the efficacy and safety of MIP as an adjunct in Category I pulmonary TB patients | NCT00341328 | (2) |
| RUTI® | Detoxified, fragmented M.tb contained in liposomes | Phase 2, randomized, double-blind, placebo-controlled interventional trial to assess the therapeutic vaccine, RUTI against TB |
NCT01136161, NCT04919239 |
(3, 4) |
| Vaccae™ | Heat-inactivated Mycobacterium vaccae | Phase 3, randomized, double-blind, interventional trial to assess the safety and efficacy to prevent TB in high-risk groups of TB infection | NCT01979900 | (5) |
| Live attenuated vaccines | ||||
| MTBVAC | Live attenuated M.tb vaccine with PhoP and FadD26 deletions | Phase 3, randomized, quadruple masking intervention to determine safety, efficacy and immunogenicity in newborns | NCT04975178 | (6) |
| VPM1002 | Live recombinant BCG vaccine strain with urease C deletion engineered to express listeriolysin rather than urease C | Phase 3, multicenter, double-blind, randomized, active-controlled trial to examine the safety, efficacy and immunogenicity to prevent M.tb infection | NCT04351685 | (7) |
| Subunit vaccines | ||||
| M72/ASO1E | Fusion protein subunit vaccine based on 32A and 39A prepared in AS01E adjuvant | Phase 2, randomized, interventional clinical trial to determine the efficacy of TB vaccine candidate in Adults | NCT01755598 | (8) |
| H56:IC31 | Recombinant vaccine comprising proteins of M.tb (85B, ESAT6, Rv2660c) and IC31 adjuvant | Phase 2, randomized (1:1), double-blind, placebo-controlled trial to determine efficacy of H56:IC31 in preventing rate of TB recurrence | NCT03512249 | (9) |
| GamTBvac | Recombinant subunit vaccine formulation comprising modified Ag85a and ESAT6-CFP10 M.tb antigens and CpG ODN adjuvant | Phase 3, randomized, multicentered, double-blind, placebo-controlled intervention to determine safety and efficaciousness of GamTBvac against pulmonary TB | NCT04975737 | (10) |
| ID93/GLA-SE | ID93 is a recombinant fusion protein comprising 4 antigens from virulence-associated proteins in GLA-SE i.e., oil-in-water emulsion | Phase 2a, randomized, placebo-controlled, double-blind intervention to evaluate safety and effectiveness of ID93/GLA-SE in TB patients | NCT02465216 | (11) |