BCG-EVs

Stage of Development

Proof of Concept – Animal Model

Vaccine Platform

Mycobacterial – Inactivated

Candidate Overview

This vaccine comprises EVs derived from Mycobacterium bovis and Escherichia coli Nissle 1917. BCG-EVs carry multiple molecules, including known protective TB antigens. The EVs will be lyophilized to ensure physicochemical stability and eliminate the need for a cold chain. Owing to their acellular nature, the vaccine is suitable for infants and children, including those living with HIV.

Sponsor / Lead Developer: National Institute of Infectious Diseases, Japan Institute for Health Security

Development partner(s): TuBerculosis Vaccine Initiative (TBVI), Niigata University, Osaka Metropolitan University

Primary Indication: Prevention of Mtb infection or sustained infection

Other Indication(s): Prevention of TB disease and Prevention of TB recurrence

Target Population(s): Adolescents, Adults, Children, Elderly, Infants, People living with HIV, and People with Mtb infection

Target Route of Administration: Intranasal

Immune tissue localization: Lung and Upper respiratory tract

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

Preclinical Animal Models: Mouse

Intended to elicit trained immunity: Yes

Additional Immunologic Response Information

	HYPOTHESIZED	DEMONSTRATED
Immune Response	B-cell/Antibody	T-cell
T-cell phenotype	(phenotyping ongoing)
T-cell functional profile		IFN-γ
Characteristics of B-cell response	Mucosal IgA Systemic IgG
Preferential immune tissue localization		Lung Upper respiratory tract
Trained immunity		Yes