H56:IC31
Candidate Overview
H56:IC31 is an adjuvanted subunit vaccine that combines three M. tuberculosis antigens (Ag85B, ESAT-6 and Rv2660c) with the IC31® adjuvant, from Valneva Austria GmBH.
Sponsor / Lead Developer: Statens Serum Institut
Development partner(s):
Valneva, IAVI
Primary Indication: Prevention of TB recurrence
Other Indication(s): Prevention of TB disease
Target Population(s): Adults and People with Mtb infection
Clinical Trials
ACTIVE TRIALS |
|
| Registry Listing | NCT03512249 |
| Clinical Trial Phase | Phase 2b |
| Status | Active |
| Primary endpoint(s) for this clinical trial | Prevention of TB recurrence |
| Target population(s) for clinical trial | Adults |
| People with active TB | |
COMPLETED TRIALS |
|
| Registry Listing | NCT01865487 |
| Clinical Trial Phase | Phase 1/2a |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| People with Mtb infection | |
| People without Mtb infection | |
_________________________ |
|
| Registry Listing | NCT02503839 |
| Clinical Trial Phase | Phase 1 |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Immunogenicity | |
| Target population(s) for clinical trial | Adults |
| People with active TB | |
_________________________ |
|
| Registry Listing | NCT02378207 |
| Clinical Trial Phase | Phase 1 |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Immunogenicity | |
| Target population(s) for clinical trial | Adolescents |
| People with Mtb infection | |
_________________________ |
|
| Registry Listing | NCT02375698 |
| Clinical Trial Phase | Phase 1 |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| People with active TB | |
_________________________ |
|
| Registry Listing | NCT01967134 |
| Clinical Trial Phase | Phase 1 |
| Status | Completed |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| People with Mtb infection | |
| People without Mtb infection | |
Related Publications
- A Phase I/II randomized trial of H56:IC31 vaccination and adjunctive cyclooxygenase-2-inhibitor treatment in tuberculosis patients (Nat. Commun., 2021)
- A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in Mycobacterium tuberculosis-uninfected adolescents in Cape Town, South Africa (EClinicalMedicine, 2020)
- A comparison of antigen-specific T cell responses induced by six novel tuberculosis vaccine candidates (PLOS Pathog., 2019)
- Dose Optimization of H56:IC31 Vaccine for Tuberculosis-Endemic Populations: A Double-Blind, Placebo-controlled, Dose-Selection Trial (Am. J. Respir. Crit. Care Med., 2019)
- First-in-human trial of the post-exposure tuberculosis vaccineH56:IC31 in Mycobacterium tuberculosis infected and non-infected healthy adults (Vaccine, 2015)