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Novel and Optimized Diagnostics for Pediatric TB

Award Number: R01AI152159
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: 05/07/2020
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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Novel and Optimized Diagnostics for Pediatric TB - In response to RFA AI-19-036, investigators from Rutgers University, Makerere University, the Foundation for Innovative New Diagnostics (FIND), McGill University, Frontier Sciences Boston, the US Centers for Disease Control and Prevention, the Kenyan Medical Research Institute and Oxford University propose to study Novel and Optimized Diagnostics (NOD) for Pediatric TB in a prospective study of well-characterized cohorts of children <5 years of age in Uganda and by accessing the biorepository from a pediatric diagnostic study in Kenya. The study populations are enriched for human immunodeficiency virus (HIV)-infected and HIV-exposed, uninfected (HEU) children. The major advances in the diagnosis of adult tuberculosis (TB) have not extended to pediatric TB. There are several reasons for this. Most children in high burden countries with symptoms compatible with TB have limited access to clinical and laboratory facilities necessary for the diagnosis. Even at referral centers where diagnosis is feasible, because of the paucibacillary nature of pediatric TB only a small proportion of children that have a compatible clinical presentation can be bacteriologically confirmed. The current bacteriologic reference standard for TB diagnosis requires difficult to obtain respiratory samples and has limited sensitivity. The impact of HIV infection of and HIV-exposure on diagnostic accuracy is uncertain. Under- and misdiagnosis of pediatric TB contributes to the high case-fatality rates that are highest in children <5 years of age and in those with HIV infection. The novel approaches for TB diagnosis in children < 5 year of age that we propose address the current needs: a) Point-of-care (POC) tests that avoid collections of respiratory specimens; b) increasing the proportion of bacteriologically-confirmed cases with more sensitive diagnostics; and, c) stratification of children with unconfirmed TB by their likelihood of having TB. We hypothesize that novel diagnostics that are currently available or further optimized and new diagnostics based on whole genome sequencing (WGS) of cell free DNA can address each of these needs. We will accomplish these goals in 3 specific aims: 1. Evaluate and develop novel assays that diagnose TB by detecting Mycobacterium tuberculosis (MTB) bacterial products in non-sputum body fluids comparing highly characterized children with microbiologically confirmed TB versus children suspected but deemed unlikely to have TB (unlikely TB). 2. Evaluate and develop novel assays that diagnose TB by detecting host biomarkers in non-sputum body fluids comparing children with confirmed TB versus unlikely TB. 3. Identify combinations of assays that applied together could be used to diagnose TB among children suspected of having TB but that are culture negative (unconfirmed TB). We will propose a new reference standard for the diagnosis of TB that might contain host and bacteria-based assays. Once validated in large observational studies and clinical trials, it could allow targeting of TB treatment in children currently classified as unconfirmed.


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: 2024 ( Subtotal = $1,142,223 )
2024	2024	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	004	5	5/3/2024	NON-COMPETING CONTINUATION	$1,142,223
2024	2023	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	003	4	4/11/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2024	2023	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	001	4	10/12/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,079,720
2024	2022	RUTGERS, THE STATE UNIVERSITY	185 S ORANGE AVE	NEWARK	NJ	07103	ESSEX	USA	Allergy and Infectious Diseases Research	000	3	10/12/2023	NON-COMPETING CONTINUATION	-$902,776
2024	2022	RUTGERS, THE STATE UNIVERSITY	185 S ORANGE AVE	NEWARK	NJ	07103	ESSEX	USA	Allergy and Infectious Diseases Research	002	3	10/12/2023	SUPPLEMENT FOR EXPANSION	-$176,944
														Subtotal = $1,142,223

Issue Date FY: 2023 ( Subtotal = $1,308,846 )
2023	2023	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	003	4	8/21/2023	SUPPLEMENT FOR EXPANSION	$219,999
2023	2023	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	65 BERGEN ST	NEWARK	NJ	07107	ESSEX	USA	Allergy and Infectious Diseases Research	002	4	4/13/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,088,847
2023	2022	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	185 S ORANGE AVE	NEWARK	NJ	07103	ESSEX	USA	Allergy and Infectious Diseases Research	000	3	10/28/2022	NON-COMPETING CONTINUATION	$0
2023	2022	RUTGERS THE STATE UNIVERSITY OF NEW JERSEY	185 S ORANGE AVE	NEWARK	NJ	07103	ESSEX	USA	Allergy and Infectious Diseases Research	001	3	4/13/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,308,846

Issue Date FY: 2022 ( Subtotal = $1,342,442 )
2022	2022	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	185 S ORANGE AVE	NEWARK	NJ	07103	ESSEX	USA	Allergy and Infectious Diseases Research	002	3	8/23/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	185 S ORANGE AVE	NEWARK	NJ	07103	ESSEX	USA	Allergy and Infectious Diseases Research	001	3	8/3/2022	SUPPLEMENT FOR EXPANSION	$219,999
2022	2022	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	185 S ORANGE AVE	NEWARK	NJ	07103	ESSEX	USA	Allergy and Infectious Diseases Research	000	3	4/28/2022	NON-COMPETING CONTINUATION	$1,122,443
														Subtotal = $1,342,442

Issue Date FY: 2021 ( Subtotal = $1,119,258 )
2021	2021	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	185 S ORANGE AVE	NEWARK	NJ	07103	ESSEX	USA	Allergy and Infectious Diseases Research	000	2	4/23/2021	NON-COMPETING CONTINUATION	$1,119,258
														Subtotal = $1,119,258

Issue Date FY: 2020 ( Subtotal = $1,085,066 )
2020	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	185 S ORANGE AVE	NEWARK	NJ	07103	ESSEX	USA	Allergy and Infectious Diseases Research	000	1	5/7/2020	NEW	$1,085,066
														Subtotal = $1,085,066

Grand Total All Awards = $5,997,835

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Novel and Optimized Diagnostics for Pediatric TB

Award Number: R01AI152159

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: 05/07/2020

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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