Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Evaluating Clinical and Immunological Consequences of SARS-CoV-2 Vaccination in Rheumatic Disease

Award Number: R01AR080356
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/01/2021
PERIOD OF PERFORMANCE END DATE: 11/30/2025

Group Awards By:

View Award Description

Evaluating Clinical and Immunological Consequences of SARS-CoV-2 Vaccination in Rheumatic Disease - The current SARS-CoV-2 pandemic has had devastating consequences, with more than 110,000,000 cases and 2,400,000 deaths worldwide. Beyond the direct effects of SARS-CoV-2 infection, much of the morbidity and mortality stems from dysregulated activation of the immune system that culminates in systemic manifestations ranging from cytokine storm to autoimmunity. Recent work suggests that the basis for observed autoimmune complications of SARS-CoV-2 infection resides in the high degree of sequence overlap between viral proteins and native tissue antigens. Given this sequence overlap and the potential for molecular mimicry/induction of autoimmunity in the setting of SARS-CoV-2 infection, there is concern that vaccines geared towards the generation of protective immune responses against the SARS-CoV-2 spike protein may increase the risk of autoreactivity—particularly in patients with pre-existing autoimmune disease and associated immune dysregulation. Because patients with underlying autoimmune diseases such as idiopathic inflammatory myopathy, systemic sclerosis, rheumatoid arthritis, and primary Sjogren’s syndrome were not included in the original trials of vaccines targeting the SARS-CoV-2 spike protein, there is a clear unmet need to better understand the consequences of SARS-CoV-2 vaccination in these patient populations—both in terms of vaccine response as well as the potential for disease exacerbation/development of de novo autoimmune manifestations. Coupled with our well-established, longitudinal rheumatic disease database/biorepository that includes an integrated data management system (RDMS=Rheumatic Disease Data Management System), our experience with the use of remote digital platforms and assessment of patient reported outcomes (PROs) makes us uniquely positioned to conduct successful observational studies of vaccine-induced clinical/immunological responses. To evaluate the relationship between changes in clinical disease activity and vaccine-induced autoreactivity, we have 3 specific aims. In Specific Aim 1, we will use general as well as disease-specific PROs at defined time points pre- and post-vaccination to assess changes in disease activity over a 12 month period—and compare these changes to pre-vaccination fluctuations in disease activity over a parallel time frame. In Specific Aim 2, we will apply novel, radiolabel-free methods of immunoprecipitation and Difference in Gel Electrophoresis to assess corresponding serum samples collected at pre- and post-vaccination time points and define vaccine- induced shifts in autoantibody profile as well as the development of anti-spike protein antibodies. In Specific Aim 3, we will use different statistical models to evaluate the relationship between these antibody profiles and changes in clinical disease activity/de novo autoimmune manifestations. Successful completion of these aims will directly address the existing knowledge gap surrounding vaccine responses in understudied rheumatic disease patient populations and establish a clinical cohort/biorepository that will serve as an unparalleled resource for biomarker development as well as future research in vaccine-associated immune alterations.


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 = -$5,757 )
2026	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	6/18/2026	NON-COMPETING CONTINUATION	-$5,757
														Subtotal = -$5,757

Issue Date FY: 2024 ( Subtotal = $237,514 )
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	6/10/2024	NON-COMPETING CONTINUATION	$17,140
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	11/17/2023	NON-COMPETING CONTINUATION	$220,374
														Subtotal = $237,514

Issue Date FY: 2023 ( Subtotal = $209,880 )
2023	2023	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	2/22/2023	NON-COMPETING CONTINUATION	$209,880
														Subtotal = $209,880

Issue Date FY: 2022 ( Subtotal = $207,958 )
2022	2022	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	11/30/2021	NEW	$207,958
														Subtotal = $207,958

Grand Total All Awards = $649,595

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Evaluating Clinical and Immunological Consequences of SARS-CoV-2 Vaccination in Rheumatic Disease

Award Number: R01AR080356

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 12/01/2021

PERIOD OF PERFORMANCE END DATE: 11/30/2025

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer