ALHA

Stage of Development

Proof of Concept – Animal Model

Vaccine Platform

Protein / Adjuvant

Candidate Overview

Ag85A-LpqH (AL) is a recombinant subunit vaccine that combines the T cell-stimulating antigen Ag85A with the humoral immunity-targeting antigen LpqH. It is constructed using the pET-21a(+) vector, expressed in E. coli BL21(DE3), and formulated with aluminum for subcutaneous administration.

Sponsor / Lead Developer: China Agricultural University

Primary Indication: Prevention of Mtb infection or sustained infection

Other Indication(s): Immunotherapy/Improving TB Cure Rates, Immunotherapy/Shortening TB treatment, Prevention of TB disease, and Prevention of TB recurrence

Target Population(s): Adolescents, Adults, Children, Elderly, Infants, People cured of active TB, People living with HIV, People with active TB, People with MDR-TB, People with Mtb infection, and People without Mtb infection

Target Route of Administration: Intramuscular

Immune tissue localization: Lung and Lymph node

Immunological responses: B-cell/Antibody and T-cell

Preclinical Animal Models: Mouse

Intended to elicit trained immunity: No

Additional Immunologic Response Information

	HYPOTHESIZED	DEMONSTRATED
Immune Response		T-cell B-cell/Antibody
T-cell phenotype		CD4 CD8 Th1
T-cell functional profile		IFN-γ TNF-α IL-17 Cytolytic capacity Mycobacterial growth inhibition
Characteristics of B-cell response		1.Strong antibody response: High titers of IgG (including IgG1, IgG2c, IgG3), IgM, and IgA, especially in the ALA group. 2.Long lasting immunity: Antibody levels remain high up to 4 weeks post infection. 3.Protective function: Serum enhances macrophage phagocytosis and reduces bacterial load and lung damage. 4.Increased BCR diversity: Notable rise in BCR diversity (IGL/IGK), with distinct V J gene usage. 5.IgG1 dominance: BCR repertoire shows higher IgG, particularly IgG1.
Preferential immune tissue localization	Lung	Lymph node
Trained immunity	Yes