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Isolation of broadly protective monoclonal antibodies for Crimean Congo Hemorrhagic Fever

Award Number: R01AI180125
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: 07/01/2025
PERIOD OF PERFORMANCE END DATE: 06/30/2029

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Isolation of broadly protective monoclonal antibodies for Crimean Congo Hemorrhagic Fever - Background/Rationale: Crimean-Congo Hemorrhagic Fever (CCHF) is the most widely distributed tick-borne viral hemorrhagic fever infection in the world. CCHF is potentially fatal and there is currently no vaccine or specific therapy for this disease. Monoclonal antibodies (mAbs) have been discovered that have shown ability to protect; however, their limited protective breadth are a liability. Objectives: The premise of this grant is that the humoral response raised against natural CCHF infection in humans leads to antibody responses that can be protective. The hypothesis is that cross-protective anti- CCHFV mAbs can be found and isolated from humans. We have data demonstrating that mouse monoclonal antibodies can be protective, and have isolated GP38 and GC mAbs from humans. The specific aims of this proposal are 1) Develop a cohort of CCHF survivors and isolate a panel of monoclonal antibodies against CCHFV envelope subjects with broad responses to Gc, Gn, and/or GP38. 2) Test the efficacy of anti-CCHFV envelope mAbs for their ability for cross-clade protection in a lethal mouse model. 3) Define the fine specificity of the broadly protective human mAb(s) against CCHFV. Methods: We will develop a cohort, analyze blood samples from 120 CCHF survivors in Turkey, and identify the patients with the broadest breadth and neutralization, and undertake a detailed isolation and characterization of up to 75 anti-CCHFV glycoprotein antibodies. Nine antibodies will then be selected for sequential efficacy testing in the IFNAR-/- mouse model in up to five separate strains representing different clades to identify broadly cross-protective mAbs. Four cross-protective mAbs will be chosen for fine epitope mapping. Monoclonal antibodies in complex with a variety of CCHFV antigens will undergo x-ray crystallography and cryo-EM. Impact: If our hypothesis proves correct, the isolation of human monoclonal antibodies that are cross-protective will represent a breakthrough, and will be candidates for further pre-clinical and clinical testing. In addition, the identification of an epitope would have implications for vaccine design against this virus.


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: 2025 ( Subtotal = $670,283 )
2025	2025	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	2	9/2/2025	NON-COMPETING CONTINUATION	$611,747
2025	2025	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	001	2	9/4/2025	SUPPLEMENT FOR EXPANSION	$58,536
														Subtotal = $670,283

Issue Date FY: 2024 ( Subtotal = $685,980 )
2024	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	1	7/23/2024	NEW	$685,980
														Subtotal = $685,980

Grand Total All Awards = $1,356,263

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Isolation of broadly protective monoclonal antibodies for Crimean Congo Hemorrhagic Fever

Award Number: R01AI180125

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: 07/01/2025

PERIOD OF PERFORMANCE END DATE: 06/30/2029

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