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H56:IC31

BIOLOGICAL7 trials

Sponsors

Aeras, Anne Margarita Dyrhol Riise, International AIDS Vaccine Initiative

Conditions

Latent TuberculosisLatent Tuberculosis Bacteriology and Histology UnknownTuberculosisTuberculosis InfectionTuberculosis, Pulmonary

Phase 1

Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis
CompletedNCT01967134
AerasLatent Tuberculosis, Latent Tuberculosis Bacteriology and Histology Unknown
Start: 2011-11-30End: 2013-06-30Updated: 2019-08-21
A Phase I Study of Safety & Immunogenicity of AERAS-456 in HIV-Neg. Adults Treated for Drug-susceptible Pulmonary TB
CompletedNCT02375698
AerasTuberculosis
Start: 2014-11-21End: 2016-10-24Updated: 2024-07-30
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
CompletedNCT02378207
AerasTuberculosis
Start: 2015-05-31End: 2016-12-09Updated: 2019-11-18
Therapeutic Vaccination and Immune Modulation - New Treatment Strategies for the MDR Tuberculosis Pandemic
CompletedNCT02503839
Anne Margarita Dyrhol RiiseTuberculosis
Start: 2015-11-30End: 2020-03-23Updated: 2022-04-08

Phase 2

A Phase II Study of H56:IC31 in Healthy Adolescents
WithdrawnNCT03265977
AerasTuberculosis Infection
Start: 2018-06-30End: 2021-06-30Updated: 2018-04-10
Study to Evaluate H56:IC31 in Preventing Rate of TB Recurrence
CompletedNCT03512249
International AIDS Vaccine InitiativeTuberculosis, Pulmonary
Start: 2019-01-31End: 2023-03-20Updated: 2026-02-24

Unknown Phase

A-043 Phase II study to Evaluate Safety, Immunogencity and Prevention of Infection with Mtb of H56:IC31 in Healthy Adolescents
Active, not recruitingPACTR201704002006214
AerasTuberculosis
Start: 2017-06-30Target: 1400Updated: 2026-09-14

Related Papers

Towards culture-free sequencing of Mycobacterium tuberculosis: evaluating new targeted and whole-genome approaches for genotyping and drug resistance profiling
Genome Medicine2026-07-21
Immunogenicity, safety, and efficacy of the vaccine H56:IC31 in reducing the rate of tuberculosis disease recurrence in HIV-negative adults successfully treated for drug-susceptible pulmonary tuberculosis: a double-blind, randomised, placebo-controlled, phase 2b trial.
2025-03-057 citations
Safety and Immunogenicity of the H56:IC31 Tuberculosis Vaccine Candidate in Adults Successfully Treated for Drug-Susceptible Pulmonary Tuberculosis: A Phase 1 Randomized Trial
The Journal of Infectious Diseases2024-04-0110 citations
Whole blood RNA signatures in tuberculosis patients receiving H56:IC31 vaccine as adjunctive therapy
Frontiers in Immunology2024-02-161 citations
The Cyclooxygenase 2 Inhibitor Etoricoxib as Adjunctive Therapy in Tuberculosis Impairs Macrophage Control of Mycobacterial Growth
The Journal of Infectious Diseases2023-09-186 citations
A Phase I/II randomized trial of H56:IC31 vaccination and adjunctive cyclooxygenase-2-inhibitor treatment in tuberculosis patients
Nature Communications2021-11-2264 citations
A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in <i>Mycobacterium tuberculosis</i>-uninfected adolescents in Cape Town, South Africa.
2020-03-1860 citations