ID93+GLA-SE (QTP101)
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)
Clinical Trial Status: Active Trials
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, Adults, and Elderly
Target Route of Administration: Intramuscular
Clinical Trials
ACTIVE TRIALS |
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| Registry Number | NCT06714513 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | Quratis Inc. |
| Primary endpoint(s) for this clinical trial | Safety |
| Immunogenicity | |
| Target population(s) for clinical trial | Elderly |
COMPLETED TRIALS |
|
| Registry Number | NCT03806686 |
| Clinical Trial Phase | Phase 2a |
| Clinical Trial Sponsor | Quratis Inc. |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| People without Mtb infection | |
| Results/Publication | Safety and Immunogenicity of the ID93 + GLA-SE Tuberculosis Vaccine in BCG-Vaccinated Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial(Infect Dis Ther, 2023) |
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| Registry Number | NCT03806699 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | Quratis Inc. |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adolescents |
| People without Mtb infection | |
_________________________ |
|
| Registry Number | NCT02508376 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
_________________________ |
|
| Registry Number | NCT02465216 |
| Clinical Trial Phase | Phase 2a |
| Clinical Trial Sponsor | Access to Advanced Health Institute (AAHI) (formerly IDRI) |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| People cured of TB | |
| Results/Publication | Safety and immunogenicity of the adjunct therapeutic vaccine ID93 + GLA-SE in adults who have completed treatment for tuberculosis: a randomised, double-blind, placebo-controlled, phase 2a trial (Lancet Respir. Med., 2020) |
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|
| Registry Number | NCT03722472 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | AAHI |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| Results/Publication | Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults (Nt. Commun., 2023) |
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|
| Registry Number | NCT01927159 |
| Clinical Trial Phase | Phase 1 |
| Sponsor | AAHI |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| Results/Publication | Safety and immunogenicity of the novel tuberculosis vaccine ID93 + GLA-SE in BCG-vaccinated healthy adults in South Africa: a randomised, double-blind, placebo-controlled phase 1 trial (Lancet Respir. Med., 2018) |
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|
| Registry Number | NCT01599897 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | AAHI |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| Results/Publication | The TLR-4 agonist adjuvant, GLA-SE, improves magnitude and quality of immune responses elicited by the ID93 tuberculosis vaccine: first-in-human trial (NPJ Vaccines, 2018) |
Related Publications
Additional Information
Quratis is planning for a phase 2b/3 dose exploration and efficacy, safety, and immunogenicity trial of QTP101.
Advancing Clinical Therapeutics Globally (ACTG) is planning a Phase 2a/2b safety and immunogenicity study of ID93+GLA-SE given as a therapeutic adjunct.