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An Assay for Paenibacillus Detection in Low Resourced Settings

Award Number: R21AI196636
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: 04/03/2026
PERIOD OF PERFORMANCE END DATE: 03/31/2028

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An Assay for Paenibacillus Detection in Low Resourced Settings - An Assay for Paenibacillus Detection in Low Resourced Settings We recently identified a novel bacterial pathogen, Paenibacillus thiaminolyticus, from neonatal sepsis patients in Sub-Saharan Africa. The pathogen is highly selective for neonates, neurotropic and extremely lethal, resulting in a syndrome we have termed paenibacilliosis. The pathogen affects thousands of infants in Uganda, Kenya and Zambia and, since our initial identification of the organism in 2020, multiple cases have been reported in the US with equally poor outcomes for infected neonates. The pathogen carries resistance genes to antibiotics used as first line treatment of septic neonates and its rapid migration to the infant’s brain, often within the first few days of infection, renders it further resistant to standard therapy. We have obtained anecdotal evidence that, while standard antibiotic therapy has little impact on attenuating the disease, early intervention with tailored antibiotic therapy in cases of Paenibacillus infection can mitigate some of the more devastating sequelae of the infection. Accordingly, early detection can have a significant therapeutic benefit for patients. As one approach to early and rapid detection of the bacteria that would be suitable for low resourced areas, we propose to develop and deploy a lateral flow device for point-of-care detection of the bacteria in neonatal sepsis cases. The device is based on a collection of monoclonal antibodies we have generated and characterized that are specific for the pathogenic strains of the bacteria. Aim I of the project focuses on development and initial testing of the device. We have contracted with RayBiotech to develop a prototype lateral flow device based on purified monoclonal antibodies we will provide them. We will validate the prototype in house with purified bacteria and existing clinical samples. In Aim 2, we will field test the device with samples from the Jinja Regional Referral Hospital in Uganda obtained by our collaborators in the neonatal infectious disease clinic. These studies will allow us to determine the specificity, sensitivity and selectivity of the device, compared to the gold standard of qPCR detection. The availability of such a device would accelerate effective and appropriate therapeutic intervention in neonatal clinics, particularly in under resourced areas in sub-Saharan Africa. Moreover, the assay would potentiate a variety of follow-up studies, including clinical trials to optimize antibiotic regimens for effective treatment of paenibacilliosis as well as studies aimed at identification of the source(s) of the infection in the environment of the patient’s home as an initial step of implementing preventative measures. These studies have the potential to significantly reduce neonatal morbidity and mortality from sepsis and reduce the health care burden in this challenging environment.


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 = $267,704 )
2026	2026	PENNSYLVANIA STATE UNIVERSITY	500 UNIVERSITY DRIVE	HERSHEY	PA	17033	DAUPHIN	USA	Allergy and Infectious Diseases Research	000	1	4/3/2026	NEW	$267,704
														Subtotal = $267,704

Grand Total All Awards = $267,704

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An Assay for Paenibacillus Detection in Low Resourced Settings

Award Number: R21AI196636

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: 04/03/2026

PERIOD OF PERFORMANCE END DATE: 03/31/2028

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