DR21 DataRelease
Release Date: 04/27/2017
| SDY59: Generation of Memory T cells In Young Healthy and Immunocompromised Populations | |||||||
| Status: | New | ||||||
| Description: | To expand our study of T cell memory repertoires to include healthy children who should still be in the process of generating memory repertoires. These studies will provide data about the age dynamics of memory repertoires. In addition to children, we will examine flu-specific memory repertoires in children with autoimmune diseases who are undergoing mild immunosuppression. This should describe the effects of immunosuppressive therapy on memory formation and function. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3PUJHYDDZ | ||||||
| Subjects: | 223 | ||||||
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||
| SDY313: HLA Genetics in Pediatric Arthritis | ||||||||
| Status: | New | |||||||
| Description: | JRA (also known as JIA) includes the commonest chronic autoimmune arthropathies of childhood. The MHC is involved with respect to risk, either susceptibility or protection in a subtype specific manner with strong gender bias and differences between ethnicities. Multiple MHC effects have been shown, especially in the commonest subtype, so called early onset pauciarticular JRA (Persistent Oligo in the JIA terminology) with three or more MHC regions believed to interact in generating susceptibility. An additional feature of the disease, unlike some other forms of autoimmunity, is the relative absence of common extended or ancestral haplotypes, especially those carrying HLA-DR4 and HLA-DR7 both of which are protective. The three regions include a class I region, or an area telomeric to it, and two class II regions those around HLA DR/DQ and HLA-DP. None of the regions involved are well defined nor were the specific genes involved identified. The alleles marking these regions (HLA-DR8, 11 and HLA-DPB1*0201) are atypical for autoimmunity. This is therefore an unusual MHC contribution to autoimmunity, the elucidation of which lends itself to high throughput technologies. The genetic features, although involving arthritis, are quite distinct from adult rheumatoid arthritis except for about 5% of older children. It is proposed to construct high throughput SNP maps in a family based study. Subtypes have different MHC profiles and in the rarest and most severe form of disease, systemic onset JRA, the MHC effect is rather minimal. In this form, preliminary data involving KIR gene haplotypes is available. Pursuing these KIR gene observations is proposed. The ability to leverage ongoing phenotyping and family based sample collection ensures a large and continuously growing pool of available DMAs for this project. Some of the patients will also have extensive gene expression studies allowing a comprehensive approach to the MHC and KIR genes in JRA and its subtypes. | |||||||
| Program/Contract: |
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| DOI: | 10.21430/M33Z8QHOKB | |||||||
| Subjects: | 1156 | |||||||
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| Clinical Assessments: | None | |||||||
| SDY522: Differences in Antibody Responses Between Trivalent Inactivated Influenza Vaccine and Live Attenuated Influenza Vaccine (2011-12) Correlate With the Kinetics and Magnitude of Interferon Signaling in Children (see companion studies SDY144, SDY360) | |||||||||||
| Status: | New | ||||||||||
| Description: | The treatment of pediatric immune system dysfunctions depends upon the basic understanding of its molecular and cellular components, as well as the inherent relationships between these components. Specifically, such knowledge requires an appreciation of B-Iymphocytes, T lymphocytes, natural killer cells and dendritic cells. Research investigating these cells and their functions necessitates the availability and acquisition of peripheral blood samples from healthy children to form control data groups against which various experimental conditions can be measured. Volunteers will be asked to donate blood samples to be used to further study the circulating dendritic cell subpopulations and establish their normal ranges. Blood samples will also be used to isolate antigen specific T lymphocytes, serve as a monocyte source and establish gene signatures. | ||||||||||
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| DOI: | 10.21430/M3XZMA3XL4 | ||||||||||
| Subjects: | 20 | ||||||||||
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| SDY572: Host responses to Enteroaggregative Escherichia coli (EAEC) infection | |||||||||||||
| Status: | New | ||||||||||||
| Description: | Enteroaggregative Escherichia coli (EAEC) is increasingly recognized as a major cause of diarrheal disease globally. In the current study, we investigated the impact of zinc deficiency on the host and pathogenesis of EAEC. Several outcomes of EAEC infection were investigated including weight loss, EAEC shedding and tissue burden, leukocyte recruitment, intestinal cytokine expression, and virulence expression of the pathogen in vivo. Mice fed a protein source defined zinc deficient diet (dZD) had an 80% reduction of serum zinc and a 50% reduction of zinc in luminal contents of the bowel compared to mice fed a protein source defined control diet (dC). When challenged with EAEC, dZD mice had significantly greater weight loss, stool shedding, mucus production, and, most notably, diarrhea compared to dC mice. Zinc deficient mice had reduced infiltration of leukocytes into the ileum in response to infection suggesting an impaired immune response. Interestingly, expression of several EAEC virulence factors were increased in luminal contents of dZD mice. These data show a dual effect of dietary zinc in benefitting the host while impairing virulence of the pathogen. The study demonstrates the critical importance of zinc and may help elucidate the benefits of zinc supplementation in cases of childhood diarrhea and malnutrition. | ||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3G6QJN9D5 | ||||||||||||
| Subjects: | 159 | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY579: Assessing the role of NLRX1 during mucosal immune responses to H. pylori in mice | ||||||||||
| Status: | New | |||||||||
| Description: | Helicobacter pylori (HP) colonizes 50% of the world’s population resulting in a decades-long gastric infection. Bacterial interaction with host intracellular environment occurs via injection of bacterial components through a TIVSS or intracellular replication. HP has been recognized for its ability to modulate intracellular NOD-like receptors (NLR). Host responses toward the bacterium can result in asymptomatic, pathogenic or even favorable immunity. Mechanisms underlying the dual role of HP as a commensal versus pathogen are not completely understood. We combined computational modeling, bioinformatics and experimental validation to investigate intracellular host-HP interactions. Global transcriptomic analysis on bone marrow-derived macrophages (BMDM) in a gentamycin protection assay unveiled that intracellular colonization of HP upregulated NOD1, NOD2, NLRP3, NLRC5 and inflammasome components (Caspase-1 and -11) but suppressed regulatory NLRX1 which was inversely correlated to TRAF6, NF-B, proinflammatory cytokines and reactive oxygen species. Loss of NLRX1 facilitates bacterial clearance in BMDM and infected mice. Lastly, we constructed a computational model to shed light on complex immune responses and pathway crosstalk regulated by NLRX1 during infection. In conclusion, NLRX1 is associated with chronic bacterial persistence during H. pylori infection and it may represent an immune evasion mechanism employed by the bacterium to facilitate long-term host colonization. | |||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3L7JSJOLT | |||||||||
| Subjects: | 161 | |||||||||
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| Clinical Assessments: | None | |||||||||
| SDY587: Effect of tissue-specific PPARg deficiency in bacterial loads | ||||||||||
| Status: | New | |||||||||
| Description: | In this study WT, CD4 cre+ and LysMcre- mice were infected with H. pylori strain SS1 for six months. | |||||||||
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| DOI: | 10.21430/M3F6N2WGKO | |||||||||
| Subjects: | 747 | |||||||||
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| Publications: | None | |||||||||
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| Clinical Assessments: | None | |||||||||
| SDY588: Zinc and tryptophan effects on immunology | |||||||
| Status: | New | ||||||
| Description: | WT mice fed either nourished or RBD-Zn diet for two weeks. +/- antibiotic pre-Rx then 042wt infected to determine effect of antibiotics in model. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3O8LDLDTM | ||||||
| Subjects: | 115 | ||||||
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| Publications: | None | ||||||
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| Clinical Assessments: | None | ||||||
| SDY598: HP45 | ||||||||||
| Status: | New | |||||||||
| Description: | Eight to thirteen-weeks-old wild-type and LysMcre mice were infected with two doses (days 0 and 2) of 5x10e7 CFU of either H. pylori strain SS1 or mutant ChePep resuspended in 1X PBS. An uninfected group receiving 1X PBS was included. | |||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3XE9NAP4K | |||||||||
| Subjects: | 674 | |||||||||
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| Publications: | None | |||||||||
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| Clinical Assessments: | None | |||||||||
| SDY601: HP47 | ||||||||||
| Status: | New | |||||||||
| Description: | WT and PPARgfl/fl:LysCre+ (R2+) mice were infected with 5x10e7 CFU of different Helicobacter pylori strains (26695, SS1 and PMSS1). A control uninfected group was included for each genotype. Tissues were collected at 9 months post-infection to determine bacterial loads (stomach) and to assess the expansion of CD4 and CD8 T cells, macrophages, dendritic cells and neutrophils by flow cytometry (blood, spleen and stomach). | |||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3SB5VLQDV | |||||||||
| Subjects: | 426 | |||||||||
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| Publications: | None | |||||||||
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| Clinical Assessments: | None | |||||||||
| SDY751: MS3 peptide detection | |||||||
| Status: | New | ||||||
| Description: | MS3 peptide detection | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M39TACCIAJ | ||||||
| Subjects: | 1 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY839: Measles Immunity | |||||||||
| Status: | New | ||||||||
| Description: | None | ||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3XWLPC8A2 | ||||||||
| Subjects: | 2681 | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY983: A Mouse Model of Chronic West Nile Virus | |||||||
| Status: | New | ||||||
| Description: | Using the Collaborative Cross, a population of recombinant inbred mouse strains with high levels of standing genetic variation, we have identified a mouse model of persistent WNV disease, with persistence of viral loads within the brain. | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3D8E1D6Z8 | ||||||
| Subjects: | 121 | ||||||
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| Assays: | None | ||||||
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| SDY1015: MaHPIC: Host M. mulatta infected with P. cynomolgi | |||||||
| Status: | New | ||||||
| Description: | Malaria-naive male rhesus macaques (Macaca mulatta), approximately three years of age, were inoculated intravenously with salivary gland sporozoites produced and isolated at the Centers for Disease Control and Prevention from multiple Anopheles species (An. dirus, An. gambiae, and An. stephensi) and then profiled for clinical, hematological, parasitological, immunological, functional genomic, lipidomic, proteomic, and metabolomic measurements. The experiment was designed for 100 days, and pre- and post-100 day periods to prepare subjects and administer curative treatments respectively. The anti-malarial drug artemether was subcuratively administered selectively to several subjects during the primary parasitemia to suppress clinical complications and to all animals for curative treatment of blood-stage infections to allow detection of relapses. One subject was euthanized during the 100-day experimental period due to clinical complications. The anti-malarial drugs primaquine and chloroquine were administered to all remaining subjects at the end of the study for curative treatment of the liver and blood-stage infections, respectively. Capillary blood samples were collected daily for the measurement of CBCs, reticulocytes, and parasitemias. Capillary blood samples were collected every other day to obtain plasma for metabolomic analysis. Venous blood and bone marrow samples were collected at seven time points for functional genomic, proteomic, lipidomic, and immunological analyses. Within the MaHPIC, this project is known as "Experiment 04". This dataset was produced by Mary Galinski, Rabindra Tirouvaniziam and Tracey Lamb at Emory University. The experimental design and protocols for this study were approved by the Emory University Institutional Animal Care and Use Committee (IACUC). | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3DLU018LB | ||||||
| Subjects: | 5 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY1: Efficacy and Safety Evaluation of Allergen Immunotherapy Co-Administered with Omalizumab (an anti-IgE Monoclonal Antibody) | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | Allergic rhinitis affects 20 to 40 million Americans annually. Allergy symptoms, which can range from mild to seriously debilitating, may affect quality of life. Left untreated, allergic rhinitis can exacerbate or trigger more serious conditions, such as asthma and sinus inflammation. Individuals with allergies react to harmless particles such as dust or pollen. Proteins in the blood called IgE antibodies treat the harmless particles as invaders and trigger an immune system response. The immune response results in harmful inflammation of healthy tissues. In ragweed allergy, inflammation occurs in the airways and causes familiar allergy symptoms like sneezing, coughing, and general discomfort. Omalizumab is an investigational drug that has been shown to block the effects of IgE antibodies. The blocking effect of omalizumab is temporary, but giving the drug to people before their regular allergy shots may make the shots more effective. Participants in this study will be randomly assigned to receive injections of omalizumab or a placebo before an accelerated course of allergy shots (given over 12 weeks). The participants will return for follow-up for up to one year, and they may have as many as 27 study visits. |
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| DOI: | 10.21430/M38Y09R3R9 | ||||||||||||
| Subjects: | 159 | ||||||||||||
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| SDY2: Immune Response to Varicella Vaccination in Subjects with Atopic Dermatitis Compared to Nonatopic Controls | ||||||||||||
| Status: | Updated | |||||||||||
| Description: | This is a mechanistic, double-aim, non-randomized study that will be conducted at 2 sites, Children's Hospital Boston and National Jewish Medical and Research Center. Study participants 12 to 36 months of age with AD and without AD will be enrolled to assess immune response after varicella vaccination. Estimated Study Duration: The study is scheduled to be completed in 36 months. Subjects will only complete one scheduled study visit. Study Population: Subjects will be enrolled over a 12 month period. Subjects will be recruited at Children's Hospital Boston and National Jewish Medical and Research Center. |
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| Program/Contract: |
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| DOI: | 10.21430/M3G33VVU77 | |||||||||||
| Subjects: | 71 | |||||||||||
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| Publications: | None | |||||||||||
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| SDY3: Responses to Immunization with Keyhole Limpet Hemocyanin (KLH) Administered by Scarification and the Intradermal (ID) Route | ||||||||
| Status: | Updated | |||||||
| Description: | AD is characterized by skin inflammation and recurrent skin infections. In addition, people with AD may have a severe and sometimes fatal reaction to the smallpox vaccine called EV. KLH is a carrier protein that can be used to deliver antibodies to the body. However KLH itself, may cause an immune response. The purpose of this study is to determine the body's reaction to pure KLH in people without AD. This will be used to establish a baseline immune response and may be compared to the immune response in people with AD during future studies. This study will last 8 weeks and will have 11 study visits. Participants in this study will be randomly assigned to 1 of 4 groups. All participants will receive their immunizations at Visits 5 and 6.
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| Program/Contract: |
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| DOI: | 10.21430/M3STULGP9K | |||||||
| Subjects: | 26 | |||||||
| Study PI, contact: |
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| Assays: | None | |||||||
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| SDY4: Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | DETAILED_DESCRIPTION AD is characterized by skin inflammation and recurrent skin infections. In addition, people with AD may have a severe and sometimes fatal reaction to the smallpox vaccine called EV. KLH is a carrier protein that can be used to deliver antibodies to the body. However KLH itself, may cause an immune response. The purpose of this study is to determine the body's reaction to pure KLH in people without AD. This will be used to establish a baseline immune response and may be compared to the immune response in people with AD during future studies. This study will last 8 weeks and will have 11 study visits. Participants in this study will be randomly assigned to 1 of 4 groups. All participants will receive their immunizations at Visits 5 and 6.
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| Program/Contract: |
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| DOI: | 10.21430/M398H5TAXP | ||||||||||||
| Subjects: | 235 | ||||||||||||
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| SDY5: Analysis and Correlation of Cathelicidin Expression in Skin and Saliva of Subjects with Atopic Dermatitis and Psoriasis | ||||||||||
| Status: | Updated | |||||||||
| Description: | People with AD or psoriasis are very sensitive to skin infections and inflammations. A group of small proteins known as cathelicidins are known to be responsible for immune defense against such infections. People with AD or psoriasis seem to be missing these proteins from their skin. The purpose of this study is to determine if the amount of cathelicidins and other small proteins in saliva is a predictor for the amount found in the skin. This is a single visit observational study. People with AD or psoriasis, as well as healthy participants, are being recruited for this study. Participants will provide a detailed medical history and undergo a physical examination. In addition, saliva and blood collection, and skin punch biopsies will be performed. |
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| Program/Contract: |
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| DOI: | 10.21430/M3KLK90P9T | |||||||||
| Subjects: | 85 | |||||||||
| Study PI, contact: |
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| Publications: | None | |||||||||
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| Assays: | None | |||||||||
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| SDY6: ADVN Biomarker Registry Study | |||||||||||||||||||||||||||||
| Status: | Updated | ||||||||||||||||||||||||||||
| Description: | This protocol describes the development of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) Biomarker Registry Study. The proposed Registry is a database with a minimum of 1,000 subjects who have voluntarily agreed to provide medical and demographic information about themselves and their health status. These data will be collected until a minimum of 12 weeks prior to the end of the funding cycle to allow for final data entry, query resolution, and database lock and will be used to identify potential subjects for future studies designed to improve scientific understanding of the increased risk of complications after exposure to the smallpox vaccine for people with atopic dermatitis (AD). In addition, enrolled subjects will be asked to provide a blood sample for evaluation of biomarkers, and permission for blood sample storage to support future analyses. Provision of a blood sample for evaluation of biomarkers for future analyses will be optional for subjects under 6 years of age. |
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| DOI: | 10.21430/M3J22ZOZM9 | ||||||||||||||||||||||||||||
| Subjects: | 1231 | ||||||||||||||||||||||||||||
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| Publications: | None | ||||||||||||||||||||||||||||
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| SDY7: ADVN Biomarker Registry Study: CMI/Ab-Vaccinia Substudy | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | To measure total and specific antibody titers and T cell responses in a sample of subjects who experienced eczema vaccinatum (EV) and a group of subjects who did not suffer from EV (normal controls or healthy AD subjects). | ||||||||||||
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| DOI: | 10.21430/M3G81PA5G7 | ||||||||||||
| Subjects: | 90 | ||||||||||||
| Study PI, contact: |
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| Publications: | None | ||||||||||||
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| Assays: | None | ||||||||||||
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| SDY8: ADVN Biomarker Registry Study: CMI-HSV Substudy | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | To evaluate AD subjects cell mediated immunity CMI responses to Herpes simplex virus. | ||||||||||||
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| DOI: | 10.21430/M3GCZX3F7X | ||||||||||||
| Subjects: | 67 | ||||||||||||
| Study PI, contact: |
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| Publications: | None | ||||||||||||
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| SDY9: ADVN Biomarker Registry: Neutrophil Substudy | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | To evaluate the chemotactic function of peripheral blood leukocytes such as neutrophils in subjects with ADEH+, ADEH-, and NA controls. | ||||||||||||
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| DOI: | 10.21430/M3OP2QB064 | ||||||||||||
| Subjects: | 62 | ||||||||||||
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| Publications: | None | ||||||||||||
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| SDY10: Role of Antimicrobial Peptides in Host Defense Against Vaccinia Virus | |||||||
| Status: | Updated | ||||||
| Description: | AD is a chronic inflammatory skin disease characterized by frequent viral skin infections. Recent studies have found that components in the skin of people with AD may block AMP expression. AMPs are responsible for preventing infection from viruses. The purpose of this study is to examine small pox virus replication and AMP expression in the skin of patients with AD as well as identify other antiviral molecules involved in immune response. These findings will be compared with those of people with psoriasis or asthma, or healthy individuals. This study will consist of one study visit at which skin and blood samples will be taken. |
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| Program/Contract: |
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| DOI: | 10.21430/M3K0GCB4KL | ||||||
| Subjects: | 292 | ||||||
| Study PI, contact: |
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| Assays: | None | ||||||
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| SDY13: Analysis of the Response of Subjects with Atopic Dermatitis to Oral Vitamin D3 by Measurement of Antimicrobial Peptide Expression in Skin and Saliva | |||||||||||||||
| Status: | Updated | ||||||||||||||
| Description: | The goal of the Atopic Dermatitis Vaccinia Network (ADVN) is to research methods for preventing atopic dermatitis (AD) patients from contracting eczema vaccinatum (EV), a potentially fatal complication of smallpox vaccinations. A critical host defense defect uncovered in patients with AD is their apparent relative lack of expression of antimicrobial peptides (AMPs), specifically cathelicidins, under inflammatory conditions. AMPs are important effectors and triggers in the innate immune system, and the lack of expression in AD patients could be a key component in their susceptibility to EV. This study will examine whether or not administration of oral Vitamin D3 given over 21 days will change the AMP expression in the skin or saliva of AD subjects and healthy controls. |
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| DOI: | 10.21430/M3LARLT608 | ||||||||||||||
| Subjects: | 90 | ||||||||||||||
| Study PI, contact: |
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| Publications: | None | ||||||||||||||
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| Assays: | None | ||||||||||||||
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| SDY14: Antimicrobial Response to Oral Vitamin D3 in Patients with Psoriasis | ||||||||||||||||
| Status: | Updated | |||||||||||||||
| Description: | The goal of the Atopic Dermatitis and Vaccinia Network (ADVN) is to research methods for preventing atopic dermatitis (AD) subjects from contracting eczema vaccinatum (EV), a potentially fatal complication of smallpox vaccinations. A critical host defense defect uncovered in subjects with AD is their apparent relative lack of expression of antimicrobial peptides (AMPs), specifically cathelicidins, under inflammatory conditions. AMPs are important effectors and triggers in the innate immune system, and the lack of expression of these peptides in AD patients could be a key component in their susceptibility to EV. The main Vitamin D3 study will examine whether or not the administration of oral Vitamin D3 over 21 days will change the AMP expression in the skin and saliva of AD subjects and healthy controls. Many new avenues of research are also being explored in this subject population and require initial exploratory data to be collected to assess their potential. As an addition to the Antimicrobial Response to Oral Vitamin D protocol, this substudy protocol will provide further control information on psoriatic responses to oral vitamin D; information on bacterial colonization in AD, non-AD, and psoriatic subjects; and assess tape stripping as a noninvasive method for the measurement of cathelicidin skin expression. |
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| Program/Contract: |
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| DOI: | 10.21430/M3U5ABTPCJ | |||||||||||||||
| Subjects: | 62 | |||||||||||||||
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| Assays: | None | |||||||||||||||
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| SDY180: Systems scale interactive exploration reveals quantitative and qualitative differences in response to 2009-2010 Fluzone influenza vaccine and pneumococcal vaccine | |||||||||||||||||
| Status: | Updated | ||||||||||||||||
| Description: | Systems immunology approaches were employed to investigate innate and adaptive immune responses to influenza and pneumococcal vaccines. These two non-live vaccines show different magnitudes of transcriptional responses at different time points af- ter vaccination. Software solutions were developed to explore correlates of vaccine efficacy measured as antibody titers at day 28. These enabled a further dissection of transcriptional responses. Thus, the innate response, measured within hours in the peripheral blood, was dominated by an interferon transcriptional signature after influenza vaccination and by an inflammation signature after pneumo- coccal vaccination. Day 7 plasmablast responses induced by both vaccines was more pronounced after pneumococcal vaccination. Together, these results suggest that comparing global immune responses elicited by different vaccines will be critical to our understanding of the immune mechanisms underpinning successful vaccination. | ||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3I44H8R17 | ||||||||||||||||
| Subjects: | 46 | ||||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||||
| SDY218: Oral Immunotherapy for Childhood Egg Allergy | ||||||||||
| Status: | Updated | |||||||||
| Description: | In the United States, as many as 6% to 8% of children are affected by food allergy. In young children, allergic reactions to egg can range from mild rash to systemic anaphylaxis. The usual standard of care for allergy is complete avoidance of this food allergen and treatment of accidental systemic reactions by access to self-injected epinephrine. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since standard injection (under the skin) immunotherapy for food allergy is associated with a high rate of allergic reactions, a few studies have recently tried oral immunotherapy (OIT) in food allergy. The purpose of this study is to determine the safety and efficacy of the administration of OIT. The intent is to develop desensitization and eventually tolerance to egg allergen. This study will evaluate tolerance to egg white solid that may be gained by gradually increasing the amounts of egg white solid given to a child over a long period of time. This study will last up to 48 months. The participants will be randomly assigned to receive oral immunotherapy treatment with egg white solid or placebo. This study will include dose escalation and maintenance followed by oral food challenge (OFC). For participants receiving egg OIT, visit 1 consists of multiple small incremental doses of egg white solid. This is followed by 32-40 weeks of gradual dose escalation to a stable maintenance dose of egg white solid for at least 8 weeks. At approximately Week 44, participants are given an OFC using 5 grams of egg white solid to identify desensitized individuals. Participants and study staff are unblinded following this initial OFC. Maintenance egg OIT therapy is continued for an additional 1-3 years. Oral Food Challenges with 10 grams of egg white solid will be performed for participants on maintenance egg OIT at subsequent time points (approximately Week 96 and annually thereafter) to test for desensitization. If passed, a repeat OFC after being off therapy for 4-6 weeks will be performed to test for tolerance. An OFC to test for tolerance will use 10 grams of egg white solid and be followed by an open feeding of egg. Participants receiving placebo during dose escalation and maintenance are given an OFC using 5 grams of egg white solid to test for desensitization at approximately 44 weeks. They are unblinded at that time, continue on an egg-restricted diet, and are followed until up to 2 years. These participants will only receive an OFC at a subsequent time point if their egg Immunoglobulin E (IgE) declines to be less than 2 kilounits of antibody per liter; this OFC will use 10 grams of egg white solid and be followed by an open feeding of egg. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur. |
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| Program/Contract: |
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| DOI: | 10.21430/M3Q2O0X9Z5 | |||||||||
| Subjects: | 55 | |||||||||
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| Clinical Assessments: | None | |||||||||
| SDY364: Systems Biology Approach to Study Influenza Vaccine 2012-13 in Healthy Children (see companion studies SDY144, SDY368, SDY387) | |||||||||||
| Status: | Updated | ||||||||||
| Description: | The treatment of pediatric immune system dysfunctions depends upon the basic understanding of its molecular and cellular components, as well as the inherent relationships between these components. Specifically, such knowledge requires an appreciation of B-Iymphocytes, T lymphocytes, natural killer cells and dendritic cells. Research investigating these cells and their functions necessitates the availability and acquisition of peripheral blood samples from healthy children to form control data groups against which various experimental conditions can be measured. Volunteers will be asked to donate blood samples to be used to further study the circulating dendritic cell subpopulations and establish their normal ranges. Blood samples will also be used to isolate antigen specific T lymphocytes, serve as a monocyte source and establish gene signatures. | ||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3U11KLQFF | ||||||||||
| Subjects: | 23 | ||||||||||
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| Publications: | None | ||||||||||
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| SDY368: Systems Biology Approach to Study Influenza Vaccine 2013-14 in Healthy Children (see companion studies SDY364, SDY144, SDY387) | |||||||||||
| Status: | Updated | ||||||||||
| Description: | The treatment of pediatric immune system dysfunctions depends upon the basic understanding of its molecular and cellular components, as well as the inherent relationships between these components. Specifically, such knowledge requires an appreciation of B-Iymphocytes, T lymphocytes, natural killer cells and dendritic cells. Research investigating these cells and their functions necessitates the availability and acquisition of peripheral blood samples from healthy children to form control data groups against which various experimental conditions can be measured. Volunteers will be asked to donate blood samples to be used to further study the circulating dendritic cell subpopulations and establish their normal ranges. Blood samples will also be used to isolate antigen specific T lymphocytes, serve as a monocyte source and establish gene signatures. | ||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3VUYLMJSR | ||||||||||
| Subjects: | 22 | ||||||||||
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| Publications: | None | ||||||||||
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| SDY387: Systems Biology Approach to Study Influenza Vaccine 2010-11 in Healthy Children (see companion studies SDY144, SDY368, SDY387) | |||||||||||
| Status: | Updated | ||||||||||
| Description: | The treatment of pediatric immune system dysfunctions depends upon the basic understanding of its molecular and cellular components, as well as the inherent relationships between these components. Specifically, such knowledge requires an appreciation of B-Iymphocytes, T lymphocytes, natural killer cells and dendritic cells. Research investigating these cells and their functions necessitates the availability and acquisition of peripheral blood samples from healthy children to form control data groups against which various experimental conditions can be measured. Volunteers will be asked to donate blood samples to be used to further study the circulating dendritic cell subpopulations and establish their normal ranges. Blood samples will also be used to isolate antigen specific T lymphocytes, serve as a monocyte source and establish gene signatures. | ||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M34N2JOQQM | ||||||||||
| Subjects: | 22 | ||||||||||
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| SDY465: Exploring the human maternal microbiome and its contribution to preterm birth | |||||||
| Status: | Updated | ||||||
| Description: | Preterm births occur in 12 percent of pregnancies. Preterm infants are at risk for long term health problems such as impaired hearing and vision, cerebral palsy and developmental delays. This study will characterize the human maternal microbiome and host response profiles associated with term and preterm births and identify features of each that are predicitive of preterm labor and delivery | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3D491LGDT | ||||||
| Subjects: | 47 | ||||||
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| SDY475: Characterization of the human maternal immune response 6 months or greater post delivery via cytometry Time-of-Flight(CyTOF). | |||||||
| Status: | Updated | ||||||
| Description: | Preterm births occur in 12 percent of pregnancies. Preterm infants are at risk for long term health problems such as impaired hearing and vision, cerebral palsy and developmental delays. This study will characterize the human maternal preterm birth immune system using Cytometry-Time-of-Flight analysis of whole blood | ||||||
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| DOI: | 10.21430/M3D8CS7ILY | ||||||
| Subjects: | 23 | ||||||
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| SDY660: LEAP ITN032AD: Induction of Tolerance through Early Introduction of Peanut in High-Risk Children, LEAP-On ITN049AD: The Persistence of Oral Tolerance Induction to Peanut and Its Immunological Basis | |||||||
| Status: | Updated | ||||||
| Description: | ITN032AD: Allergic reactions to peanuts are potentially life-threatening and, in some children, can result from ingestion of only trace quantities of peanuts. At highest risk are children with eczema or who are allergic to eggs; these children have a 20% chance of developing peanut allergy by the age of five. The majority of children allergic to peanuts have their first reaction between the ages of 14 and 24 months, often at the time of their first exposure to peanut. Currently, there is no cure for peanut allergy.Peanut allergy has become an increasingly common problem in early childhood in the United States and the United Kingdom. Despite current public health guidelines in both countries recommending the avoidance of peanut consumption in the first years of life, the proportion of children with peanut allergy doubled in these countries over the period from 1998 to 2003. In contrast, peanuts are commonly consumed by infants in relatively high amounts in Africa, Southeast Asia and Israel, yet the rate of peanut allergy is quite low and does not appear to be increasing. Peanut consumption by infants in these parts of the world may actually protect children from developing peanut allergy by promoting oral tolerance to peanuts.Participants in this study will be randomly assigned to either follow a peanut consumption regimen or a strict peanut avoidance regimen. Those assigned to the peanut consumption group will be asked to consume an age-appropriate snack three times a week for the duration of the study and will be monitored closely during their first introduction to peanut.Those assigned to the peanut avoidance group will be asked to avoid ingestion of peanut for the first three years of life. A physical exam, allergy testing, and other immune system tests requiring blood collection will occur at Years 1, 3, and 5 following study entry. During the study, parents will maintain regular contact with study dietitians. ITN049AD: This is a two-sample comparison employing all available study participants in both arms of the current LEAP study at V72. After obtaining informed consent LEAP participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled into the LEAP-On Study. All LEAP-On participants will avoid peanut for an additional 12 months regardless of their previous allocation to the LEAP Study consumption arm (Group A) or the LEAP Study avoidance arm (Group B). At V72, after 12 months of this new intervention, all participants will have skinprick testing, specific IgE and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. The LEAP Study decision table will be used to determine the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. Tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms). | ||||||
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| DOI: | 10.21430/M3SFPACKA3 | ||||||
| Subjects: | 640 | ||||||
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| Assays: | None | ||||||
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| SDY691: HLA and KIR Haplotype Sequencing | |||||||
| Status: | Updated | ||||||
| Description: | Assay development for complete HLA and KIR haplotype sequencing from cell lines | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3RES1FXTG | ||||||
| Subjects: | 97 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY939: Pathologically expanded peripheral B cell-helper T cells in Rheumatoid Arthritis | |||||||
| Status: | Updated | ||||||
| Description: | CD4+ T cells are central mediators of autoimmune pathology; however, | ||||||
| Program/Contract: |
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| DOI: | 10.21430/M3OLBPJIB1 | ||||||
| Subjects: | 4 | ||||||
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