ID93+GLA-SE (QTP101)

Vaccine Platform

Protein / Adjuvant

Phase of Development

Phase 2a

Candidate Overview

ID93+GLA-SE / QTP101 consists of the active pharmaceutical ingredient, a recombinant protein ID93, and an adjuvant, GLA-SE. The ID93 recombinant protein is composed of the four Mtb antigens Rv3619, Rv1813, Rv3620, and Rv2608 linked in tandem. GLA is a molecule similar to synthetic monophosphoryl lipid A (MPL®) as a TLR4 agonist.

Sponsor / Lead Developer: Quratis (QTP101); NIAID/NIH (ID93+GLA-SE)

Primary Indication: Prevention of TB disease

Other Indication(s): Prevention of Mtb infection or sustained infection and Prevention of TB recurrence

Target Population(s): Adolescents and Adults

Clinical Trials

COMPLETED TRIALS
Registry NumberNCT03806686
Clinical Trial PhasePhase 2a
Clinical Trial SponsorQuratis Inc.
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
People without Mtb infection
_________________________
Registry NumberNCT03806699
Clinical Trial PhasePhase 1
Clinical Trial SponsorQuratis Inc.
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdolescents
People without Mtb infection
_________________________
Registry NumberNCT02508376
Clinical Trial PhasePhase 1
Clinical Trial SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
_________________________
Registry NumberNCT02465216
Clinical Trial PhasePhase 2a
Clinical Trial SponsorAccess to Advanced Health Institute (AAHI) (formerly IDRI)
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
People cured of TB
_________________________
Registry NumberNCT03722472
Clinical Trial PhasePhase 1
Clinical Trial SponsorAAHI
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
_________________________
Registry NumberNCT02465216
Clinical Trial PhasePhase 2a
Clinical Trial SponsorAAHI
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
People cured of TB disease
_________________________
Registry NumberNCT01927159
Clinical Trial PhasePhase 1
SponsorAAHI
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
_________________________
Registry NumberNCT01599897
Clinical Trial PhasePhase 1
Clinical Trial SponsorAAHI
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults

Additional Information

Quratis is planning for a phase 2b/3 dose exploration and efficacy, safety, and immunogenicity trial of QTP101.

NIAID/NIH is planning a Phase 2a/2b safety and immunogenicity study of ID93+GLA-SE given as a therapeutic adjunct.