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Mechanisms of New-Onset Autoimmunity/Longitudinal Immune Systems Analysis (MONA-LISA)

Award Number: U01AI176135
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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Mechanisms of New-Onset Autoimmunity/Longitudinal Immune Systems Analysis (MONA-LISA) - PROJECT SUMMARY/ABSTRACT The Mechanisms of New-Onset Autoimmunity-Longitudinal Immune Systems Analysis (MONA-LISA) will use clinical data and biospecimens obtained during performance of the clinical trial, Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE, NCT03030118) to investigate immunological mechanisms that propel individuals who have asymptomatic or minimally symptomatic autoimmunity towards a definite diagnosis of systemic lupus erythematosus. These data and specimens are a unique resource, representing longitudinal clinical assessments, patient-reported outcomes, DNA, RNA, serum, plasma, peripheral blood mononuclear cells and urine obtained in a standardized manner before, during, and after the progression from Incomplete Lupus Erythematosus to Systemic Lupus Erythematosus (SLE) – an observation that occurred in twenty percent of the SMILE participants available for study. The overall objective of the study is to learn the underlying immunological, genomic, and metabolic differences present in individuals who progress to SLE compared to those that do not progress with goals to both develop better diagnostic and prognostic tools for health care providers as well as describe novel therapeutic targets so that individuals with early features of autoimmunity can be prevented from progressing to a state of organ damage and disability. The Specific Aims of MONA-LISA include: 1) Obtain a comprehensive, multiplex analysis of the peripheral blood immunophenotype of progressors and non-progressors in the SMILE cohort using a novel 137-plex CITE-seq analysis, sn-ATAC-seq, sc-RNA-seq and T and B cell repertoire determination to create a robust, quantitative atlas of cell-specific mRNA and epigenomic profiling in PBMC of these individuals. 2) Perform targeted genomic sequencing to categorize regulatory and structural variants of SLE risk loci to tie together the transcriptomic and epigenomic data and create novel risk assessments based on gene regulation. 3) Explore plasma and serum metabolic and lipid components that can serve as novel features that classify the risk of SMILE participants who progress towards classification with lupus. 4) Lastly, because SMILE enrolled fewer Black individuals than are represented in the epidemiology of prevalent lupus patients, we will perform a focused recruitment of non-European individuals with ILE and compare their multi-omic characterization of immunophenotypes described in Aims 1-3. This will allow more complete and generalizable conclusions to be drawn across ethnic groups and identify any ancestry-specific variations in the risk of autoimmunity progression that can explain the observed differences in lupus epidemiology. When completed, MONA-LISA will provide researchers and health care providers with better tools to predict who will develop lupus and create more effective interventional trials for disease prevention.


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 = $1,252,131 )
2025	2025	THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Allergy and Infectious Diseases Research	000	3	4/15/2025	NON-COMPETING CONTINUATION	$1,252,131
														Subtotal = $1,252,131

Issue Date FY: 2024 ( Subtotal = $1,474,549 )
2024	2024	THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Allergy and Infectious Diseases Research	003	2	9/11/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2024	THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Allergy and Infectious Diseases Research	001	2	4/15/2024	NON-COMPETING CONTINUATION	$125,827
2024	2024	THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Allergy and Infectious Diseases Research	002	2	7/17/2024	SUPPLEMENT FOR EXPANSION	$216,290
2024	2024	UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, THE	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Allergy and Infectious Diseases Research	000	2	3/11/2024	NON-COMPETING CONTINUATION	$1,132,432
														Subtotal = $1,474,549

Issue Date FY: 2023 ( Subtotal = $1,291,119 )
2023	2023	UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, THE	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Allergy and Infectious Diseases Research	001	1	4/12/2023	NEW	$0
2023	2023	UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, THE	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Allergy and Infectious Diseases Research	000	1	3/22/2023	NEW	$1,264,971
2023	2023	UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, THE	5323 HARRY HINES BLVD	DALLAS	TX	75390	DALLAS	USA	Allergy and Infectious Diseases Research	002	1	4/24/2023	NEW	$26,148
														Subtotal = $1,291,119

Grand Total All Awards = $4,017,799

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Mechanisms of New-Onset Autoimmunity/Longitudinal Immune Systems Analysis (MONA-LISA)

Award Number: U01AI176135

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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