H56:IC31

Vaccine Platform

Protein / Adjuvant

Phase of Development

Phase 2b

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 ListingNCT03512249
Clinical Trial PhasePhase 2b
StatusActive
Primary endpoint(s) for this clinical trialPrevention of TB recurrence
Target population(s) for clinical trialAdults
People with active TB
COMPLETED TRIALS
Registry ListingNCT01865487
Clinical Trial PhasePhase 1/2a
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
People with Mtb infection
People without Mtb infection
_________________________
Registry ListingNCT02503839
Clinical Trial PhasePhase 1
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Immunogenicity
Target population(s) for clinical trialAdults
People with active TB
_________________________
Registry ListingNCT02378207
Clinical Trial PhasePhase 1
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Immunogenicity
Target population(s) for clinical trialAdolescents
People with Mtb infection
_________________________
Registry ListingNCT02375698
Clinical Trial PhasePhase 1
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
People with active TB
_________________________
Registry ListingNCT01967134
Clinical Trial PhasePhase 1
StatusCompleted
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
People with Mtb infection
People without Mtb infection