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A novel hyper-immunogenic low virulent BCG vaccine against tuberculosis

Award Number: R01AI175837
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/03/2023
PERIOD OF PERFORMANCE END DATE: 04/20/2025

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A novel hyper-immunogenic low virulent BCG vaccine against tuberculosis - SUMMARY Human morbidity and mortality due to tuberculosis (TB), caused by the bacterial pathogen Mycobacterium tuberculosis (Mtb), continue to be of significant health concern throughout the world. Bacille Calmette-Guerin (BCG) still remains the only approved vaccine against TB. Although BCG is considered safe and partially effective against extra-pulmonary childhood TB, its ability to protect against childhood and adult pulmonary TB is still questionable. In addition, there is a concern that BCG does not induce long lasting immune responses in the immunized individuals. However, our findings with Mtb- and BCG- derived recombinant vaccines strongly suggest that BCG can be improved to be more efficacious against TB. The goal of this proposal is to improve BCG by rationally deleting genes. We plan to sequentially delete three genes of BCG namely sapM, zmp1 and nuoG, through homologous recombination, to result in a triple knockout BCG (BCG-TKO) strain. These genes encode proteins that enable BCG to evade host immune response by preventing phagosome-lysosomal fusion, autophagy, apoptosis and other related processes in the antigen presenting cells (APCs) such as dendritic cells and macrophages. We hypothesize that deletion of these genes will allow the BCG-TKO strain to be efficiently processed by APCs, which will lead to increased antigen presentation to the immune cells and enhanced in vivo immunogenicity and efficacy. Additionally, we anticipate that deletion of these genes will reduce the virulence of the BCG, thus making the BCG-TKO to be HIV safe. We plan to accomplish our goal with three aims: 1) construct a BCG-TKO strain through homologous recombination, 2) analyze the immunogenicity and safety of the BCG-TKO strain in a SCID mouse model, and 3) investigate the efficacy of the BCG-TKO in the regular and humanized mouse models with and without HIV infection. Overall, we expect that this proposal will produce a highly efficacious, third generation BCG vaccine against TB that will be suitable for administration even in HIV infected infants.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $643,430 )
2026	2026	THE UNIVERSITY OF TEXAS RIO GRANDE VALLEY	1201 W UNIVERSITY DR	EDINBURG	TX	78539	HIDALGO	USA	Allergy and Infectious Diseases Research	001	4	12/29/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$643,430
2026	2025	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	130 RICK FRANCIS ST	EL PASO	TX	79905	EL PASO	USA	Allergy and Infectious Diseases Research	000	3	12/29/2025	NON-COMPETING CONTINUATION	$0
2026	2025	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	130 RICK FRANCIS ST	EL PASO	TX	79905	EL PASO	USA	Allergy and Infectious Diseases Research	002	3	2/18/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $643,430

Issue Date FY: 2025 ( Subtotal = $458,789 )
2025	2025	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	130 RICK FRANCIS ST	EL PASO	TX	79905	EL PASO	USA	Allergy and Infectious Diseases Research	000	3	1/23/2025	NON-COMPETING CONTINUATION	$458,789
														Subtotal = $458,789

Issue Date FY: 2024 ( Subtotal = $452,019 )
2024	2024	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	130 RICK FRANCIS ST	EL PASO	TX	79905	EL PASO	USA	Allergy and Infectious Diseases Research	001	2	5/23/2024	NON-COMPETING CONTINUATION	$45,201
2024	2024	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Allergy and Infectious Diseases Research	000	2	1/17/2024	NON-COMPETING CONTINUATION	$406,818
														Subtotal = $452,019

Issue Date FY: 2023 ( Subtotal = $462,379 )
2023	2023	TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO	5001 EL PASO DR	EL PASO	TX	79905	EL PASO	USA	Allergy and Infectious Diseases Research	000	1	2/3/2023	NEW	$462,379
														Subtotal = $462,379

Grand Total All Awards = $2,016,617

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A novel hyper-immunogenic low virulent BCG vaccine against tuberculosis

Award Number: R01AI175837

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/03/2023

PERIOD OF PERFORMANCE END DATE: 04/20/2025

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