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Active Vaccination and Passive Antibody Strategies to Prevent Disease Caused by Multidrug-Resistant Bacterial Pathogens

Award Number: U19AI142725
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Active Vaccination and Passive Antibody Strategies to Prevent Disease Caused by Multidrug-Resistant Bacterial Pathogens - CETR OVERALL ABSTRACT Widespread antimicrobial resistance (AMR), both in the USA and globally, has made it increasingly difficult to treat enteric and invasive nosocomial bacterial infections that were previously responsive to antimicrobials. Among the most important enteric bacterial pathogens that cause severe clinical disease and death if they cannot be treated with effective antibiotics are ones that cause diarrhea, dysentery or enteric fever. Some bacterial enteric pathogens are epidemiologically emerging or re-emerging, e.g.: multi-drug resistant H58 lineage of Salmonella Typhi; S. Paratyphi A; multi-drug resistant Shigella; drug-resistant Campylobacter jejuni and Clostridium difficile. A few bacterial enteropathogens are of special interest from the civilian biodefense perspective, as they have been used by nefarious individuals to promulgate bioterror (non-typhoidal Salmonella [NTS]), or have properties that suit them to such a purpose (Shigella dysenteriae 1). Two of the most important opportunistic drug-resistant bacterial pathogens that cause invasive infections in compromised hosts are Klebsiella pneumoniae and Pseudomonas aeruginosa. Vaccines and other preventives against these pathogens can ameliorate the AMR problem by preventing clinical disease, thereby precluding the need to administer antibiotics and relieving selection pressure. The five projects described in this Center of Excellence for Translational Research (CETR) proposal, bonded by the theme “Active Vaccination and Passive Antibody Strategies to Prevent Disease Caused by Multidrug-Resistant Bacterial Pathogens”, will undertake translational research towards developing the following countermeasures to prevent disease caused by important multi-drug resistant bacterial pathogens: an improved Shigella live vector vaccine consisting of 6 attenuated strains of key serotypes, each expressing protective antigens to prevent clinical illness caused by ETEC, as well as Shigella (Project 1); engineered attenuated NTS strains representing serogroups B, C1, C2 & D to serve as a multivalent broadly protective live oral vaccine (Project 2); a conjugate vaccine consisting of O polysaccharides of K. pneumoniae serotypes O1, O2, O3 & O5, representing the vast majority of invasive isolates, linked to flagellin type A or B of P. aeruginosa, to prevent invasive disease (Project 3); the probiotic yeast Saccharomyces boulardii engineered to secrete antibodies against K. pneumoniae fimbriae that mediate intestinal colonization, thereby diminishing a major risk factor (colonization) for invasive disease (Project 3); recombinant S. boulardii that secrete antibodies directed against C. difficile toxins and somatic antigens or against flagellin of C. jejuni, administered orally to inhibit gut colonization and prevent diarrheal disease (Project 4); a compendium of immune response measurements to Salmonella serovars to identify correlates of protection and guide development of broadly protective live oral Salmonella vaccines (Project 5). Translational research will advance these countermeasures to where Investigational New Drug Applications (IND) can be prepared to initiate Phase 1 clinical trials.


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 = $0 )
2024	2023	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	5	2/1/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $2,500,000 )
2023	2023	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	001	5	2/28/2023	NON-COMPETING CONTINUATION	$2,500,000
2023	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	4	2/1/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,500,000

Issue Date FY: 2022 ( Subtotal = $2,500,000 )
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	001	4	3/4/2022	NON-COMPETING CONTINUATION	$2,500,000
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	3	12/17/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,500,000

Issue Date FY: 2021 ( Subtotal = $2,500,000 )
2021	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	002	3	3/4/2021	NON-COMPETING CONTINUATION	$2,500,000
2021	2020	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	001	2	3/2/2021	NON-COMPETING CONTINUATION	$0
2021	2020	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	2	12/4/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,500,000

Issue Date FY: 2020 ( Subtotal = $2,500,000 )
2020	2020	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	2	3/3/2020	NON-COMPETING CONTINUATION	$2,500,000
														Subtotal = $2,500,000

Issue Date FY: 2019 ( Subtotal = $2,500,000 )
2019	2019	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	1	3/14/2019	NEW	$2,500,000
														Subtotal = $2,500,000

Grand Total All Awards = $12,500,000

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Active Vaccination and Passive Antibody Strategies to Prevent Disease Caused by Multidrug-Resistant Bacterial Pathogens

Award Number: U19AI142725

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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