DR10 DataRelease
Release Data: 06/01/2014
| SDY286: Modeling Pulmonary Immunity: Evaluation of the Innate Immune Response to Pathogens 1) Francisella tularensis 2) Mycobacterium tuberculosis and 3) Influenza A virus in cynomolgus macaque | |||||||||
| Status: | New | ||||||||
| Description: | A greater understanding of how alveolar macrophages respond to pathogens is important for the design of novel therapeutic agents for treatment of potentially lethal pulmonary infections. To increase understanding of early pulmonary infection response of macaques following infection with viral and bacterial pathogen, alveolar macrophages were used to determine the similarities and differences between species to invading pulmonary pathogens | ||||||||
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| DOI: | 10.21430/M3EAOXZB4O | ||||||||
| Subjects: | 24 | ||||||||
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| Clinical Assessments: | None | ||||||||
| SDY288: Modeling Pulmonary Immunity: Evaluation of the Innate Immune Response to Pathogens 1) Francisella tularensis 2) Mycobacterium tuberculosis and 3) Influenza A virus in mice (C57BL/6 and BALB/c) | |||||||||||||
| Status: | New | ||||||||||||
| Description: | A greater understanding of how alveolar macrophages respond to pathogens is important for the design of novel therapeutic agents for treatment of potentially lethal pulmonary infections. To increase understanding of early pulmonary infection response of mice following infection with viral and bacterial pathogen, alveolar macrophages were used to determine the similarities and differences between species to invading pulmonary pathogens | ||||||||||||
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| DOI: | 10.21430/M3H9VMI0DF | ||||||||||||
| Subjects: | 876 | ||||||||||||
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| Clinical Assessments: | None | ||||||||||||
| SDY61: Systems Biology of 2007 Influenza Vaccination in Humans (See companion studies SDY269 2008 / SDY270 2009 / SDY271 Role for CaMKIV in the Regulation of Antibody Responses to Influenza Vaccine) | |||||||||||
| Status: | Updated | ||||||||||
| Description: | Using a systems biology approach to study innate and adaptive responses to influenza vaccination in humans during the 2007-2008 influenza season. | ||||||||||
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| DOI: | 10.21430/M3FH0SA2W0 | ||||||||||
| Subjects: | 12 | ||||||||||
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| Clinical Assessments: | None | ||||||||||
| SDY162: Immunologic and genomic signatures of response to Hepatitis C Virus infection. | |||||||
| Status: | Updated | ||||||
| Description: | Examine the immune response in primary immune cells from subjects who have spontaneously cleared HCV compared to HCV chronically infected subjects | ||||||
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| DOI: | 10.21430/M3TI5NZ7VL | ||||||
| Subjects: | 20 | ||||||
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| Clinical Assessments: | None | ||||||
| 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. | ||||||||||||||||
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| DOI: | 10.21430/M3I44H8R17 | ||||||||||||||||
| Subjects: | 46 | ||||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||||
| SDY201: Responses to Influenza Vaccination in Systemic Lupus Year 6 2010-2011 | |||||||||||
| Status: | Updated | ||||||||||
| Description: | Influenza is an important pathogen in the United States, with approximately 20,000 deaths per year, mainly among elderly people or those with underlying medical conditions that increase susceptibility to complications from the disease. In addition, considerable morbidity is associated with influenza with a significant impact in productivity in the workplace and home. Influenza has the potential for much more serious consequences as demonstrated by the appearance of four world-wide pandemics in the last century. In principle, serious influenza outbreaks can be prevented by vaccination. However, vaccination is complicated by two features: First, the influenza virus undergoes frequent mutations in the genes encoding the surface proteins hemagglutinin (HA) and neuraminidase (NA), leading to the need to reformulate the vaccine every year. Second, the appearance of the rapidity with which influenza infections can spread. Thus, influenza holds significant potential as a bioterrorism agent. Lupus patients have an increased risk of infection and mount lower responses to vaccinations. The objectives of this study will use genetic, cellular and humoral techniques to identify and explain abnormalities in the immune response to influenza vaccination in lupus patients. The results will clarify vaccine effectiveness among affected patients, increase the understanding of immune dysregulation in lupus, and aid in establishing guidelines for the effective vaccination of lupus patients. The benefits to the subjects are not direct; however, information gained may improve responses of reducing or preventing influenza among the affected population. Additionally, with an increased understanding of the processes of lupus, targets for disease intervention or strategies for treatment may appear. | ||||||||||
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| DOI: | 10.21430/M35J0WA7CR | ||||||||||
| Subjects: | 34 | ||||||||||
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| SDY210: Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies | |||||||
| Status: | Updated | ||||||
| Description: | Over the past two decades, the prevalence of asthma has dramatically increased in many parts of the world. The current National Asthma Education and Prevention Program (NAEPP) identifies inhaled corticosteroids (ICS) as the preferred long-term control therapy for all forms of persistent asthma. However, there is still a significant proportion of patients with persistent asthma who are not receiving ICS therapy or do not follow their treatment plan. Individualized asthma treatment plans are needed. The use of biomarkers, in addition to NAEPP guidelines, may help enhance the level of asthma assessment, guide medication regimens, and improve overall asthma control. This study will determine whether NAEPP-recommended treatment, combined with eNO measurement, is more effective in reducing asthma symptoms than NAEPP-recommended treatment alone. ICAC-01 will last 46 weeks and will comprise 8 study visits. ICAC-01 also includes a mechanistic sub-study (ICAC-02). Its primary objective is to determine whether highly sensitized, compared to weakly sensitized asthmatic subjects have more severe asthma, as defined by the levels at randomization to the completion of ICAC-01. To address the primary objective of ICAC-02, the study will include all the participants enrolled in ICAC-01 with dust mite-, cockroach- and/or alternaria-specific IgE levels within certain parameters. | ||||||
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| DOI: | 10.21430/M3I0JL7KUZ | ||||||
| Subjects: | 546 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY212: Apoptosis and other immune biomarkers predict influenza vaccine (TIV 2008) responsiveness | |||||||||||||
| Status: | Updated | ||||||||||||
| Description: | Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to indentify benchmarks of immunological health, influenza vaccination was used in 30 young (20-30 years) and 59 older subjects (60 to 89 years) as models for strong and weak immune responses, respectively. Serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation were measured. Using machine learning, nine variables predicting antibody response with 84% accuracy were identified. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health. | ||||||||||||
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| DOI: | 10.21430/M37NGTHMDS | ||||||||||||
| Subjects: | 91 | ||||||||||||
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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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| DOI: | 10.21430/M3Q2O0X9Z5 | |||||||||
| Subjects: | 55 | |||||||||
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| Clinical Assessments: | None | |||||||||
| SDY269: Systems Biology of 2008 Influenza Vaccination in Humans (See companion studies SDY61 2007 / SDY270 2009 / SDY271 Role for CaMKIV in the Regulation of Antibody Responses to Influenza Vaccine) | |||||||||||||||
| Status: | Updated | ||||||||||||||
| Description: | Using a systems biology approach to study innate and adaptive responses to influenza vaccination in humans during the 2008-2009 influenza season. | ||||||||||||||
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| DOI: | 10.21430/M3CDX6TL4I | ||||||||||||||
| Subjects: | 63 | ||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||