31 completed, 1 unknown, 1 withdrawn. 18 Phase 1, 13 Phase 2, 2 Early Phase 1, 1 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 18 | Completed 18 |
| Phase 2 | 13 | Completed 12, Withdrawn 1 |
| Early Phase 1 | 2 | Completed 2 |
| Not applicable | 1 | Completed 1 |
| Phase 4 | 1 | Unknown 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase II Study of H56:IC31 in Healthy Adolescents H56:IC31, Placebo - Tuberculosis Infection | Phase 2 | Withdrawn | Aeras | 2018-06-01 | 2018-04-10 | |
| Biological Samples Obtained by Leukapheresis Induced by Two BCG Vaccinations in BCG-naïve Healthy Adults in the US bacillus Calmette-Guérin - Tuberculosis | Early Phase 1 | Completed | Aeras | 15 | 2017-08-08 | 2019-09-04 |
| Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents H4:IC31, H56:IC31, BCG - Tuberculosis | Phase 1 | Completed | Aeras | 84 | 2015-05-01 | 2019-11-18 |
| Leukapheresis Sampling for Immune Responses After BCG Vaccination in BCG-naïve Healthy Adults in the US BCG - Tuberculosis | Early Phase 1 | Completed | Aeras | 10 | 2015-05-01 | 2015-10-09 |
| A Phase I Study of Safety & Immunogenicity of AERAS-456 in HIV-Neg. Adults Treated for Drug-susceptible Pulmonary TB H56:IC31, Placebo - Tuberculosis | Phase 1 | Completed | Aeras | 22 | 2014-11-21 | 2024-07-30 |
| Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults GSK Biologicals' investigational TB vaccine (GSK692342), Placebo - Tuberculosis, Tuberculosis Vaccines | Phase 2 | Completed | GlaxoSmithKline | 3575 | 2014-08-19 | 2019-12-03 |
| Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972) Tuberculosis | Completed | Aeras | 3253 | 2014-08-01 | 2017-02-01 | |
| A Clinical Challenge Study of BCG in Healthy Volunteers BCG SSI, BCG Tice - Tuberculosis | Not applicable | Completed | University of Oxford | 52 | 2014-03-01 | 2015-01-22 |
| Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents AERAS-404, Placebo, Bacillus Calmette-Guérin (BCG) - Tuberculosis | Phase 2 | Completed | Aeras | 989 | 2014-02-01 | 2019-09-04 |
| Phase I Trial of DAR-901 DAR-901, BCG, Sterile saline - Tuberculosis | Phase 1 | Completed | Dartmouth-Hitchcock Medical Center | 59 | 2014-02-01 | 2016-08-02 |
| Phase 1 ID93 + GLA-SE Vaccine Trial in BCG-Vaccinated Healthy Adult Volunteers ID93 + GLA-SE, Placebo - Pulmonary Tuberculosis | Phase 1 | Completed | Access to Advanced Health Institute (AAHI) | 66 | 2013-09-01 | 2018-02-01 |
| A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456) H56ug/IC31nmol, Placebo - Latent Tuberculosis Bacteriology and Histology Unknown, Latent Tuberculosis | Phase 1 / Phase 2 | Completed | Aeras | 98 | 2013-08-01 | 2019-12-19 |
| Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants AERAS-404, Placebo - Tuberculosis | Phase 1 / Phase 2 | Completed | Aeras | 243 | 2013-07-01 | 2018-04-09 |
| Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A AERAS-402, MVA85A - Tuberculosis | Phase 1 | Completed | University of Oxford | 40 | 2012-09-01 | 2014-09-17 |
| Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342 GSK Biologicals' investigational TB vaccine GSK 692342 - Tuberculosis | Phase 2 | Completed | GlaxoSmithKline | 20 | 2012-08-21 | 2019-03-22 |
| Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers ID93 + GLA-SE, ID93 alone - Pulmonary Tuberculosis | Phase 1 | Completed | Access to Advanced Health Institute (AAHI) | 60 | 2012-08-01 | 2017-09-15 |
| Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis H56:IC31 - Latent Tuberculosis, Latent Tuberculosis Bacteriology and Histology Unknown | Phase 1 | Completed | Aeras | 25 | 2011-11-01 | 2019-08-21 |
| Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in HIV-Infected Adults (C-030-485) MVA85A/AERAS-485, Placebo - Tuberculosis, HIV Infections | Phase 2 | Completed | Aeras | 650 | 2011-07-01 | 2016-05-24 |
| A Study to Evaluate Safety and Immunogenicity of AERAS-402 AERAS 402, Placebo - Tuberculosis | Phase 1 | Completed | Aeras | 12 | 2011-02-01 | 2014-03-17 |
| A Study for Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults BCG SSI, Placebo, AERAS-404 - Tuberculosis | Phase 1 | Completed | Aeras | 70 | 2011-01-01 | 2017-01-24 |
Showing 20 of 33. Sign in to see all of them.
Tuberculosis (30) · Latent Tuberculosis (3) · HIV Infections (2) · Tuberculosis, Pulmonary (2)
AERAS-402 (5) · BCG Vaccine (3) · MVA 85A (3) · Heptavalent Pneumococcal Conjugate Vaccine (1) · Saline Solution (1) · Tromethamine (1)
South Africa (17) · United States (4) · Kenya (3) · United Kingdom (2) · Belgium (1) · Finland (1) · India (1) · Mozambique (1) · Senegal (1) · Sweden (1) · Switzerland (1) · Tanzania (1) · The Gambia (1) · Zambia (1)
Angelique Luabeya, MD (2) · Bernard Landry, MPH (2) · Dereck Tait, MD (2) · Helen McShane (2) · Zhongkai Shi, MD (2) · Ann Ginsberg, MD, PhD (1) · Ann M Ginsberg, MD PhD (1) · Ann M. Ginsberg, MD, PhD (1) · Anna Marie Beckmann, PhD (1) · Avy Violari, MD (1) · Bernard Landry (1) · Bernard Landry, MS (1) · Charles F. von Reyn, MD (1) · Daniel Hoft, MD (1)
PMID 28216183, PMID 19008268, PMID 22296955, PMID 24912498, PMID 26048780, PMID 26072017, PMID 26450421, PMID 26529238, PMID 26554383, PMID 27322481, PMID 28060545, PMID 28498853, PMID 29595510, PMID 29685114, PMID 29996082, PMID 30092143, PMID 30210819, PMID 30280651, PMID 31120957, PMID 31661198, PMID 31697647, PMID 32382714
U01AI068632 (1)