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Immunotherapy to prevent drug-resistant tuberculosis

Award Number: R01AI125160
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: 05/01/2016
PERIOD OF PERFORMANCE END DATE: 11/30/2022

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Immunotherapy to prevent drug-resistant tuberculosis - Project Summary / Abstract Mycobacterium tuberculosis (Mtb) resistant to current first-line antibacterial agents is a serious and growing public health threat, causing nearly 500,000 new tuberculosis (TB) cases and 170,000 deaths annually. Treatments for drug-sensitive disease are lengthy, complex, and patient noncompliance exacerbates the development of drug-resistant (DR) TB cases, for which treatments are even more prolonged, toxic, expensive, and have lower cure rates. The current proposal is designed to develop an innovative combination regimen using an existing second line drug, Capreomycin, a new class of superior bactericidal antibiotic, Sutezolid, and a candidate therapeutic vaccine delivered as an inhaled product that offers significant potential to improve treatment of DR-TB. An effective treatment that targets both the pathogen and boosts the host immune response to accelerate bacterial clearance, prevent relapse, and shorten therapy, would play an important role in dramatically reducing the impact of the Mtb pathogen. We will leverage the strength of proprietary vaccine adjuvants, and a clinical stage vaccine antigen, ID93, that has entered Phase 2 human clinical testing. This application is an extension of our systematic and methodical approach towards controlling TB. Over the last twenty years, we have applied this strategy towards developing viable vaccine candidates such as M72/AS01E and ID93/GLA- SE (both in clinical stage testing). At present, to our knowledge, ID93/GLA-SE is the sole TB vaccine candidate in the pipeline that has been tested for efficacy against DR-TB, as well as for prophylaxis and therapy in multiple animal models of TB. Funding this R01 project to develop a candidate therapeutic vaccine used as adjunctive treatment with drugs for DR-TB will address this global infectious disease threat.


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: 2023 ( Subtotal = -$747 )
2023	2020	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Allergy and Infectious Diseases Research	000	5	9/28/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$747
														Subtotal = -$747

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Allergy and Infectious Diseases Research	000	5	8/4/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	SEATTLE CHILDREN'S HOSPITAL	4800 SAND POINT WAY NE	SEATTLE	WA	98105	KING	USA	Allergy and Infectious Diseases Research	002	5	4/6/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$822,604
2021	2019	INFECTIOUS DISEASE RESEARCH INSTITUTE	1616 EASTLAKE AVE E STE 400	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	001	4	4/6/2021	NON-COMPETING CONTINUATION	-$802,216
2021	2018	INFECTIOUS DISEASE RESEARCH INSTITUTE	1616 EASTLAKE AVE E STE 400	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	3	4/6/2021	NON-COMPETING CONTINUATION	-$20,388
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,268,943 )
2020	2020	SEATTLE CHILDREN'S HOSPITAL	4800 SAND PT WAY NE	SEATTLE	WA	98105	KING	USA	Allergy and Infectious Diseases Research	003	5	9/4/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$417,584
2020	2020	SEATTLE CHILDREN'S HOSPITAL	4800 SAND PT WAY NE	SEATTLE	WA	98105	KING	USA	Allergy and Infectious Diseases Research	001	5	5/29/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,387,155
2020	2020	SEATTLE CHILDREN'S HOSPITAL	4800 SAND PT WAY NE	SEATTLE	WA	98105	KING	USA	Allergy and Infectious Diseases Research	002	5	6/5/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2020	2019	INFECTIOUS DISEASE RESEARCH INSTITUTE	1616 EASTLAKE AVE E STE 400	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	4	5/28/2020	NON-COMPETING CONTINUATION	-$535,796
														Subtotal = $1,268,943

Issue Date FY: 2019 ( Subtotal = $1,338,012 )
2019	2019	INFECTIOUS DISEASE RESEARCH INSTITUTE	1616 EASTLAKE AVE E STE 400	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	4	4/23/2019	NON-COMPETING CONTINUATION	$1,338,012
														Subtotal = $1,338,012

Issue Date FY: 2018 ( Subtotal = $1,337,935 )
2018	2018	INFECTIOUS DISEASE RESEARCH INSTITUTE	1616 EASTLAKE AVE E STE 400	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	3	4/19/2018	NON-COMPETING CONTINUATION	$1,337,935
														Subtotal = $1,337,935

Issue Date FY: 2017 ( Subtotal = $1,314,028 )
2017	2017	INFECTIOUS DISEASE RESEARCH INSTITUTE	1616 EASTLAKE AVE E STE 400	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	2	3/29/2017	NON-COMPETING CONTINUATION	$1,314,028
														Subtotal = $1,314,028

Issue Date FY: 2016 ( Subtotal = $1,315,804 )
2016	2016	INFECTIOUS DISEASE RESEARCH INSTITUTE	1124 COLUMBIA ST, SUITE 600	SEATTLE	WA	98104	KING	USA	Allergy and Infectious Diseases Research	000	1	4/29/2016	NEW	$1,315,804
														Subtotal = $1,315,804

Grand Total All Awards = $6,573,975

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Immunotherapy to prevent drug-resistant tuberculosis

Award Number: R01AI125160

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: 05/01/2016

PERIOD OF PERFORMANCE END DATE: 11/30/2022

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