Stage of Development

Proof of Concept – Animal Model

Vaccine Platform

Bacterial Vector

Candidate Overview

This TB vaccine candidate comprises a live attenuated Listeria monocytogenes vector with two major virulence gene deletions and a T-cell immunity enhancing mutation (Lm ΔactA ΔinlB prfA*) that expresses nine M. tuberculosis immunoprotective proteins (Mpt64, TB10.4, ESAT-6, CFP10, Ag85B, EsxN, PPE68, EspA, and TB8.4 – four absent from BCG) from two chromosomal fusion protein expression cassettes.

Sponsor / Lead Developer: University of California, Los Angeles (UCLA)

Primary Indication: Prevention of TB disease

Other Indication(s): Immunotherapy/Improving TB Cure Rates, Immunotherapy/Shortening TB treatment, Prevention of Mtb infection or sustained infection, and Prevention of TB recurrence

Target Population(s): Adolescents, Adults, Elderly, People without Mtb infection, and To be determined

Target Route of Administration: Subcutaneous

Immune tissue localization: Lung, Skin, and Spleen

Immunological responses: T-cell

Preclinical Animal Models: Guinea pig, Mouse, and Nonhuman primate

Intended to elicit trained immunity: Yes

Additional Immunologic Response Information

Immune ResponseT-cell
T-cell phenotypeGamma-delta (γδ)
T-cell functional profilePolycytotoxicity
Cytolytic Capacity
Mycobacterial growth inhibition
Preferential immune tissue localizationLung
Trained immunityYes

Additional Information

Vaccine has demonstrated efficacy against M. tuberculosis aerosol challenge in BALB/c mice, C57BL/6 mice, and guinea pigs.
Vaccine administered subcutaneously is cleared rapidly (1 week) from skin, lungs, and spleen of mice and guinea pigs.
Vaccine can be inexpensively grown overnight in simple broth culture without the need for extensive purification.
Parent vector (Lm ΔactA ΔinlB) has demonstrated safety in humans in multiple clinical studies.