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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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Common variable immunodeficiency (CVID) is the most prevalent symptomatic primary immunodeficiency. Respiratory ailments are the most frequent complications of CVID, with chronic pulmonary disease developing in 30-60% and even more experiencing frequent acute respiratory infections. This project aims to establish cutting-edge approaches to study pulmonary biology in CVID and apply novel bioinformatics strategies to study complex interactions among microbes and host cells by direct sampling of the respiratory tract. The central hypothesis for this research is that antibody (Ab) deficiency in CVID alters respiratory microbiota and host interactions to drive pulmonary disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibody deficient participants | Provider referred patients that have antibody deficiency. | ||
| Controls | Patients without antibody deficiency from the allergy and immunology clinic at Boston Medical Center and from healthy volunteers at the BU School of Medicine. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of respiratory sample RNA sequencing (RNAseq) analysis | Quality control analysis of RNA samples collected from nasopharyngeal swabs for adequacy to perform RNA-seq analysis will be performed. This will be done using the Boston University (BU) Medical Campus RNA core facility bioanalyzer, which will assess for adequate RNA quality and quantity for RNA-seq | 1 year |
| Analysis of saliva sampling | Saliva samples will be analyzed by enzyme-linked immunosorbent assay (ELISA) and multiplex analysis (Luminex) for levels of antibodies as well as cytokines and other inflammatory proteins. | 2 years |
| Respiratory microbiota analysis by RNA-seq of nasopharyngeal samples | RNA-seq data derived from nasopharyngeal samples will undergo computational analysis to identify alterations of microbiota constituency. | 2 years |
| Host gene expression analysis by RNA-seq of nasopharyngeal samples | RNA-seq data derived from nasopharyngeal samples will undergo computational analysis to identify alterations of host gene and pathway expression. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Altered respiratory microbiota due to primary antibody deficiency | RNA seq will be used to determine if primary antibody deficiency alters respiratory microbiota | 2 years |
| Altered gene expression due to primary antibody deficiency |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be enrolled from the Boston Medical Center allergy and immunology clinics and from healthy volunteers at the Boston University medical campus (BUMC). They will be assigned into one of two groups: antibody deficient patients and controls. Blood, nasopharyngeal swab, saliva, and sputum (if possible) samples will be collected from each participant, ideally on the same day.
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| Name | Affiliation | Role |
|---|---|---|
| Paul J Maglione, MD PhD | Boston University Chobanian & Avedisian School of Medicine, Pulmonary Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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Blood, saliva, nasopharyngeal, and sputum samples will be collected. 50 ml of blood will be collected/participant.This collection of blood will constitute the study biological sample repository. Peripheral blood mononuclear cells (PBMCs) plasma samples will be used for flow cytometry, cell culture, and enzyme-linked immunosorbent assays. RNAseq will be done on nasopharyngeal samples. Sputum samples will have measurement of lymphocyte subsets (by flow cytometry), cytokines and immunoglobulins (by multiplex ELISA), and RNA (both bacterial and host by RNA sequencing) in the laboratory.
RNA seq will be used to determine if primary antibody deficiency alters host gene expression.
| 2 years |